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NuVasive CoRoent Small Interbody System: The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of nonoperative treatment. NuVasive CoRoent Small Contoured Interbody System: The NuVasive CoRoent Small Contoured Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Contoured Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment. NuVasive CoRoent Small Interlock System: The CoRoent Small Interlock System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with autogenous or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment. NuVasive CoRoent Small Interlock II System: The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The CoRoent Small Interlock II System (lordotic angles of 7° to 15°) is a standalone system. The CoRoent Small Interlock II System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous or alloqenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to or a bone void filler as cleared by the FDA for use in intervertebral body fusion facilitate fusion. The cervical devices are to be used in patient who have had at least six weeks of non-operative treatment. NuVasive CoRoent Small Ti-C System: The NuVasive CoRoent Small Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Ti-C System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/ or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent Small interbody devices with lordotic angles of 10° or greater are required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment. NuVasive Cohere Cervical Interbody System: The Cohere® Cervical Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Vertera Spine Cohere Cervical Interbody Fusion Device is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/ or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion.

NuVasive CoRoent Small Interbody System: The NuVasive CoRoent Small Interbody System is designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The CoRoent Small Interbody System implants are hollow devices manufactured from polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Pins made of either titanium alloy (Ti-6A1-4V) conforming to ASTM F136 or ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782 serve as radiopaque markers so the location and orientation of the device may be seen radiographically during and after the procedure for position confirmation. The CoRoent Small Interbody System and accessory surgical instruments will be packaged and provided both sterile and non-sterile implants are designed to be sterilized by the user before each use. The implantation technique does not differ from that performed for the predicate CoRoent Small offerings cleared in NuVasive CoRoent Small Interbody System (K163491). The CoRoent Small Interbody offerings are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervical spine. The CoRoent Small Hyperlordotic offerings (lordotic angles of 10° to 30°) must be used with an anterior cervical plate. The CoRoent Small Interbody System is identical to the primary predicate with respect to design, footprint, material composition, mechanical performance, labeling, intended use, and sterilization. The only difference is the expansion of indications to include use with a bone void filler as cleared by the FDA for use in intervertebral body fusion. NuVasive CoRoent Small Contoured Interbody System: The NuVasive® CoRoent® Small Contoured Interbody System is designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The CoRoent Small Contoured Interbody System implants are hollow devices manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Pins made of either titanium alloy (Ti-6Al-4V) or tantalum serve as radiopaque markers allowing the location and orientation of the device to be seen radiographically during and after the procedure for position confirmation. Both the subject device and its accessory surgical instruments will be packaged and initially provided non-sterile and are designed to be sterilized by the user before each use. The implantation technique for the subject CoRoent Small Contoured Interbody System does not differ from that performed for the predicate CoRoent Small offerings cleared in CoRoent Small Interbody System (K163491). The CoRoent Small Interbody offerings are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervical spine. The CoRoent Small Contoured Interbody System is identical to the primary predicate with respect to design, footprint, material composition, mechanical performance, labeling, intended use, and sterilization. The only difference is the expansion of indications to include use with a bone void filler as cleared by the FDA for use in intervertebral body fusion and to expand indications to include treatment of degenerative disc disease (DDD) of the cervical spine at multiple contiguous levels. NuVasive CoRoent Small Interlock System: The NuVasive CoRoent Small Interlock System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with autogenous or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Pins made of either titanium alloy (Ti-6Al-4V) or tantalum serve as radiopaque markers so the location and orientation of the device may be seen radiographically during and after the procedure for position confirmation. The NuVasive CoRoent Small Interlock System is designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The CoRoent Small Interlock offerings are intended to be standalone without supplemental fixation. ThThe CoRoent Small Interlock System implants will be packaged either sterile while accessory surgical instruments will be provided non-sterile and are designed to be sterilized by the user before each use. The implantation technique does not differ from that described in primary predicate CoRoent Small Interlock System (K192582). The CoRoent Small Interlock System is identical to the primary predicate with respect to design, footprint, material composition, mechanical performance, labeling, intended use, and sterilization. The only difference is the expansion of indications to include use with a bone void filler as cleared by the FDA for use in intervertebral body fusion. NuVasive CoRoent Small Interlock II System: The NuVasive CoRoent Small Interlock II System is an intervertebral body fusion device designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The System consists of various sizes of PEEK implants with tantalum radiographic markers, titanium alloy washers and bone screws. Additionally, a commercially pure titanium (CP Ti) coating is plasma sprayed to the superior and inferior surfaces of the interbody device. The implants are manufactured from Polyetheretherketone PEEKOPTIMA® LT1 conforming to ASTM F2026, commercially pure titanium coating conforming to ASTM F1580, with titanium alloy washers and bone screws conforming to ASTM F136, ASTM F1472 or ISO 5832-3. The hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Pins made of tantalum serve as radiopaque markers so the location and orientation of the device may be seen radiographically during and after the procedure for position confirmation. The implantation technique for the subject CoRoent Small Interlock II implants (including hyperlordotic offerings) does not differ from that performed for the predicate Interlock offerings cleared in CoRoent Small Interlock System (K192582). Both the subject PEEK only interbodies, screws and accessory surgical instruments will be packaged and initially provided non-sterile and are designed to be sterilized by the user before each use. Additionally, the subject PEEK with CP Ti coating implants will be provided sterile. Non-clinical testing demonstrates that the subject device meets performance requirements set by the Agency's guidance document and is substantially equivalent to the predicate NuVasive CoRoent Small Interlock II System (K170961) NuVasive CoRoent Small Interlock System (K192582), and other predicate devices cleared by the Agency. The CoRoent Small Interlock II System is identical to the primary predicate with respect to design, footprint, material composition, mechanical performance, labeling, intended use, and sterilization. The only difference is the expansion of indications to include use with a bone void filler as cleared by the FDA for use in intervertebral body fusion and to expand indications to include treatment of degenerative disc disease (DDD) of the cervical spine at multiple contiguous levels. NuVasive CoRoent Small Ti-C System: The NuVasive CoRoent Small Ti-C System is designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The subject CoRoent Small Ti-C System implants are hollow devices manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. A commercially pure titanium (CP Ti) coating is plasma sprayed to the superior and inferior surfaces of the device. The hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Pins made of either titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782 serve as radiopaque markers so the location and orientation of the device may be seen radiographically during and after the procedure for position confirmation. The CoRoent Small Ti-C System includes several variants within its offering. Within the subject system, the CoRoent Small Interbody offerings are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervical spine. The CoRoent Small Hyperlordotic offerings (lordotic angles of 10° to 30°) must be used with an anterior cervical plate. The CoRoent Small Ti-C System is identical to the primary predicate with respect to design, footprint, material composition, mechanical performance, labeling, intended use, and sterilization. The only difference is the expansion of indications to include use with a bone void filler as cleared by the FDA for use in intervertebral body fusion and to expand indications to include treatment of degenerative disc disease (DDD) of the cervical spine at multiple contiguous levels. Overall, the subject NuVasive CoRoent Small Ti-C System device is substantially equivalent to predicates NuVasive CoRoent Small Interbody System (K163491), and NuVasive Ti-C System (K162138), as well as other predicate devices cleared by the Agency. The CoRoent Small Ti-C System will be provided sterile while its accessory general surgical instruments will be provided non-sterile and designed to be sterilized by the user before each use. The implantation technique does not differ from that performed for the predicate devices cleared in NuVasive CoRoent Small Interbody System (K163491). NuVasive Cohere Cervical Interbody System: The subject Cohere® Cervical Interbody Fusion Device (K173030) is an interbody fusion device comprised of a single, continuous piece of PEEK Scoria®, which is formed into a final product shape. The subject device remains solid with an extruded porous layer on the superior and inferior surfaces of the implant body. The porous surface is derived directly from the implant body and is not a sintered or otherwise additive coating. The hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to help promote a solid fusion. The PEEK cage contains two marker bands made of tantalum R05200 conforming to ASTM F560, which serve as radiopaque markers so the location and orientation of the device may be seen radiographically, during and after the procedure for position confirmation. The Cohere Cervical Interbody Fusion Device comes in a variety of sizes and geometries to suit the individual pathology and anatomical conditions of the patient. The devices are provided sterile, with the accessory surgical instruments packaged as non-sterile to be sterilized by the end user. All accessory instruments utilized with the subject system are the same as those referenced in K173030. A complete part number list of the Cohere Cervical Interbody Fusion Device implants is provided in this submission. This part number list is identical to the list submitted in K173030. The Cohere Cervical Interbody Fusion Device is identical to the primary predicate with respect to design, footprint, material composition, mechanical performance, labeling, intended use, and sterilization. The Cohere Cervical Interbody System is identical to the primary predicate with respect to design, footprint, material composition, mechanical performance, labeling, intended use, and sterilization. The only difference is the expansion of indications to include use with a bone void filler as cleared by the FDA for use in intervertebral body fusion.

The NuVasive Modulus ALIF System is indicated for spinal fusion procedures in skeletally mature patients. These devices are intended to be used with bone screws, anchoring blades, or a combination of the two. When used with Modulus ALIF bone screws, the Modulus ALIF System 10° 20° lordotic cages may be used as a standalone system. When used with Modulus ALIF anchoring blades, the Modulus ALIF Interfixated System must be used with supplemental internal spinal fixation systems (e.q., posterior pedicle screw and rod system) that are cleared for use in the lumbar spine. When used with either the Modulus ALIF bone screws or the Modulus ALIF anchoring blades, the Modulus ALIF Interfixated system 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems that are cleared for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment. The NuVasive Modulus ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (e.g., radiographs, CT scan, MRI scan). The Modulus ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity; however, when used in these patients at multiple levels and for patients with degenerative spondylolistheses and spinal stenosis at one or two adjacent levels, the Modulus ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by FDA for use in the lumbar spine in addition to the integrated screws/anchoring blades.

The subject NuVasive Modulus ALIF System interbody implants are manufactured from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001 Class C. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration of the device. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. When used with the Modulus ALIF bone screws, the Modulus ALIF Interfixated System 10°- 20° lordotic cages may be used as a standalone system. When used with the Modulus ALIF anchoring blades, the Modulus ALIF Interfixated System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared for use in the lumbar spine. When used with either the Modulus ALIF bone screws or the Modulus ALIF anchoring blades, the Modulus ALIF Interfixated system 25°- 30° lordotic cages must be used with supplemental internal spinal fixation systems that are cleared for use in the lumbar spine. The purpose of this submission is to introduce the Modulus ALIF anchoring blades (blades), which are a new in-line fixation option, provided sterile and non-sterile, for the NuVasive Modulus ALIF System.

The surgical instruments are specifically designed for use with the Pulse System, which enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate. When used with a Pulse Navigation system, the patient reference hardware is intended to provide a reference to a rigid anatomical structure that can be identified relative to the acquired image of the anatomy.

The subject NuVasive Rod Registration Frame is introducing modifications based on the design of existing patient reference hardware, the Spinous Process Clamp (Pulse System K210574). The Rod Registration Frame was designed to offer surgeons more flexibility during the registration process of Pulse Navigation by providing an additional patient reference hardware design option for attaching the existing Patient Reference Array to the patient. Despite the changes introduced to predicate Spinous Process Clamp (K210574), the subject device Rod Registration Frame is substantially equivalent to the predicate as demonstrated by verification and validation testing performed using well established and previously cleared test methods.

When used as a pedicle screw fixation system in skeletally mature patients, the NuVasive Reline System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Degenerative spondylolisthesis with objective evidence of neurologic impairment 3. Fracture 4. Dislocation 5. Scoliosis 6. Kyphosis 7. Spinal tumor and/or 8. Failed previous fusion (pseudoarthrosis) The Nu Vasive Reline System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline System is also intended for the following indications: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Spinal stenosis 3. Spondylolisthesis 4. Spinal deformities 5. Fracture 6. Pseudoarthrosis 7. Tumor resection and/or 8. Failed previous fusion When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline System is indicated as an adjunct to fusion to treat: 1. adolescent idiopathic scoliosis. 2. progressive spinal deformities (i.e., scoliosis, or lordosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, 3. spondylolisthesis, 4. spondylolysis, 5. pseudarthrosis, 6. failed prior fusion and 7. fracture caused by tumor and/or trauma in pediatric patients. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft. In order to achieve additional levels of fixation, the NuVasive Reline System rods may be connected to the Armada System.

The NuVasive Reline System is a pedicle screw system that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to introduce "Dual-Headed Modular Connectors" which will be included in the NuVasive Reline System. Additionally, this submission is intended to specify pediatric progressive deformities in the indications for use statement for NuVasive Reline System. Lastly, this submission is intended to add minor labeling changes to address compatibility updates to the NuVasive Reline system.

The Nu Vasive Cohere ALF System Intervertebral Body Fusion Device is indicated for spinal fusion procedures in skeletally mature patients. The Cohere ALIF System Interverebird Body Fusion Device 10-200 lordotic cages may be used as a standalone system. The System Intervetebral Body Fusion Device 25-30° lordotic cages may be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneis bone graft, intervertebral hody fraise to corticocancellous bone graft, or a bone void filler as cleared by FDA, for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had alleast sim onths of non-operative treatment. The NuVasive Cohere ALLF System Intervertebral Body Fusion Device is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectory in the trestment of symptomatic degenerative disc disease (DD) or degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disconfirmed by history and radiographic studies. The Cohere ALFE System Intervertebral Body Fusion Device implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative spondylolisthanis as saind the used in these patients at multiple levels at multiple levels and for patients with degenerative spondylolisthesis or spinal stenosis at one or two adjacent levels, the Cohere ALIF System Intervetebrah Body Fusion Device must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the internal spillal fixal.

The Cohere ALIF System Intervertebral Body Fusion Device is inclusive of sterile, single use interbody implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights. Each device within the Cohere ALIF System Intervertebral Body Fusion Devce is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. In addition to PEEK, the device assembly contains radiolucent markets to enable visibility under x-ray in vivo. The implants are available in a variety of sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The Cohere ALIF System Intervertebral Body Fusion Device 10°-20° lordotic cages may be used as a standalone system. The Cohere ALIF System Intervertebral Body Fusion Device 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

The NuVasive Reline Cervical System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Reline Cervical System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Reline Cervical System may be connected to the NuVasive SpheRx Spinal System, Precept Spinal System, Armada Spinal System, Reline 4.5-5.0 System va the rod to rod connectors or transition rods.

The NuVasive Reline Cervical System is an occipito-cervico-thoracic posterior system manufactured from Titanium alloy (Ti6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3 and Cobalt Chromium alloy conforming to ASTM F90 or ASTM F1537. The Reline Cervical System consists of a variety of components including screws, rods, offset connectors, rod to rod connectors, set screws, cross connectors, hooks, eyelets, and occipital plates which can be rigidly locked in a variety of configurations to accommodate patient anatomy.

The NuVasive MOD-EX XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. When used with or without the MOD-EX XLIF internal fixation, the system is intended for allogencis and or allogeneic bone graft comprised of cancellous and/or cortiocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for >20° lordosis is needed, the plated MOD-EX XLIF Interbody must be used along with additional supplemental fixation. The devices are to be used in patients who have had at least six months of non-operative treatment. The NuVasive MOD-EX XLIF Plated 2.0 Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is intended for use with autogeneic bone graft comprised of cancellous and/or corticocancellous bone graft or a bone void filler as cleared by FDA for use in intervertebral body fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The MOD-EX XLIF Interbody System and MOD-EX XLIF Plated 2.0 Interbody System are interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degenerative spondylolisthess at one or two adjacent levels, including thoracy disc hemiation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NaVasive MOD-EX XLF Interbody System and NuVasive MOD-EX XLIF Plated 2.0 Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive MOD-EX XLIF Interbody System and NuVasive MOD-EX XLIF Plated 2.0 Interbody System are an expandable interbody system, additively manufactured from Grade 23 titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001 Class C and traditionally manufactured from titanium alloy (Ti-6V-4A1 ELI) per ASTM F136 or ISO 5832-3. The NuVasive MOD-EX XLIF Interbody System also includes Nickel-Cobalt-Chromium-Molybdenum (MP35N) conforming to ASTM F562. The NuVasive MOD-EX XLF and NuVasive MOD-EX XLIF Plated 2.0 interbodies are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The system is designed to address thoracolumbar pathologies utilizing interbody placement through a standard lateral (XLIF) approach. The device features independent threaded drive and wedge mechanisms to allow for independent expansion of the anterior and posterior aspect of the implant. The superior and inferior endplate components are solid and porous structures manufactured simultaneously using a powder bed fusion method. The microporous, textured surfaces on the superior and inferior ends of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The NuVasive MOD-EX XLIF and NuVasive MOD-EX XLIF Plated 2.0 Interbody System interbodies have superior and inferior graft apertures, allowing for packaging of graft to aid in the promotion of a solid fusion.

The NuVasive Reline Cervical System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Reline Cervical System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Reline Cervical System may be connected to the NuVasive SpheRx Spinal System, Precept Spinal System, Armada Spinal System and Reline 4.5-5.0 System via the rod to rod connectors or transition rods.

The NuVasive Reline Cervical System is an occipito-cervico-thoracic posterior system manufactured from Titanium alloy (Ti6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3 and Cobalt Chromium alloy conforming to ASTM F90 or ASTM F1537. The Reline Cervical System consists of a variety of components including screws, rods, offset connectors, rod to rod connectors, set screws, cross connectors, hooks, eyelets, and occipital plates which can be rigidly locked in a variety of configurations to accommodate patient anatomy.

The NuVasive® ACP System is intended for anterior screw fixation of the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Nu Vasive Archon Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of the implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. Additionally, the three-hale version of the implant system may be appropriate only for patients with large vertebral bodies, and is particularly suited for use following corpectomies for the treatment of tumors and burst fractures. The NuVasive SmartPlate Gradient Plus System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. The NuVasive HELIX Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

The NuVasive Anterior Cervical Plate Systems are anterior cervical plating systems that consist of a variety of implant components including screws and plates, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject devices components are from titanium (Ti-6A1-4V) conforming to ASTM F1472/F136 and ISO 5832-3, (titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 or ISO 5832-3, and nickel-cobalt-chromium-molybdenum alloy (MP35N) per ASTM F562.