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The Tiger 2 System is a pedicle screw system intended to provide Immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deform-ities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impair-ment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Tiger 2 System when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degener-ation of the disc confirmed by history and radios), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). The Tiger 2 System Fenestrated Screws are intended to be used with saline and radiopaque dye.

The Tiger 2 System is comprised of pedicle screws, rods, hooks, rod connectors and cross connectors. The Tiger 2 System can be used for single or multiple level fixations. The pedicle screws have various options in length and diameters. The rods are available in straight and prelordosed (curved) configurations. The system has variable length cross connectors.

When used with the Zavation ZLinkPC System for Posterior-Cervical-Thoracic (Occ-T3) The Zavation Connector System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of 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/thoracic spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. When used with the Zavation Spinal System for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Illium) The Zavation Connector System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Illium) in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Connector System is designed to aid in revision surgeries and extensions of existing hardware constructs from the Occiput to the Ilium. The Connector System includes a variety of non-sterile titanium implants including parallel rod to rod domino connectors, axial connectors with and without attachment rods, bypass connectors, lateral offsets, double tulips (angled and parallel), and Z rods. The implant options allow revisions and extension to be performed without removing existing hardware. The Zavation Connector System is designed to be used with the Zavation Z-Linkpc System for Posterior-Cervical-Thoracic (Occ-T3) and the Zavation Spinal System for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Illium).

Zavation Navigated Instrument System are indicated for use during the placement of Zavation Spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Zavation Navigated Instruments are reusable and are specifically designed for use with the Medtronic Navigation StealthStation System which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. Use of Zavation Navigated Instrument System is limited to use only with Zavation Spinal System and Zavation Z-Linkec System.

The Zavation Navigation instruments non-sterile, reusable instruments that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to aid in implantation of associated Zavation screw implants. The instruments are manufactured from stainless steel per ASTM F899

The Zavation ALIF System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Zavation ALIF System is to be filled with autogenous bone graft material. The Zavation ALIF System spacer and plate assembly are an integrated for stand-alone use when used with screws. When used with anchors only the recessed plate may be used, and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine. Hyperlordotic interbody devices (>20 dogrees) must be used with supplemental fixation (c.g. posterior fixation) that has been cleared by the FDA for the use in the lumbar spine.

The Zavation ALIF System includes a spacer, plate, screws, and anchors. The spacer component is assembled to an interbody plate and implanted anteriorly. The spacer components are available in a variety of materials, depths, widths, and heights. The plate component includes three or four holes for inserting bone screws or anchors. The plate component also includes a lock at each hole. The bone screws are available in a variety of diameters and lengths. The anchors are available in a variety of lengths. The interbody plate components are available in a variety of heights.

Uni-FuZe-C Bone Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Uni-FuZe-C Bone Strip resorbs and is replaced with bone during process.

Zavation Medical's Uni-FuZe-C Bone Strip is a bioactive osteoconductive, resorbable, biocompatible bone graft substitute in strip form. The product is composed of a matrix of purified bovine collagen per ASTM F2212, beta tricalcium phosphate (Beta-TCP per ASTM F1088), and Bioglass 45S5 per ASTM F1538.

The Zavation Spinal System is a pedicle screw system intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal turnor, and failed previous fusion (pseudarthrosis). The Zavation Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Zavation Spinal System when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). The Zavation Spinal System Fenestrated Screws are intended to be used with saline and radiopaque dye.

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and cross connectors. The Zavation Spinal System can be used for single or multiple level fixations. The standard pedicle screws have various options in lengths and diameters as well as a sterile packaged Hydroxyapatite (HA) coated option. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors. The safety and effectiveness of the fenestrated screws have not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). The device is intended only to be used with saline or radiopaque dye.

The VariSync Plate is intended for anterior screw fixation to 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 VariSync Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The VariSync Spacer is to be filled with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. These devices are intended to be used with supplemental fixation such as the Zavation VariSync Plate, Zavation Midline Plate, Zavation EZ Plate, or Zavation Cervical Plate Systems. When used with the VariSync Plate, the assembly takes on the indications of the VariSync Spacer, with the VariSync Plate acting as the supplemental fixation.

The VariSync Plate is an anterior, cervical fixation device available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates are made from titanium alloy, as specified in ASTM F136. The Screws for use with the VariSync Plates are manufactured from titanium alloy, as specified in ASTM F136. VariSync Spacers are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and footprints to fit the anatomical needs of a wide variety of patients. These devices are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The VariSync Spacers are manufactured from radiolucent PEEK polymer, with tantalum markers, as specified in ASTM F2026 and F560.

The Zavation eZspand™ Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation eZspand™ Interbody System implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended to be used in patients who have had six months of non-operative treatment. The Zavation eZspand™ Interbody System implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including the Zavation Spinal System.

The Zavation eZspand™ Interbody System devices are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The implants are provided in a shape that accommodates a posterior, transforaminal or lateral approach to the lumbar spine. After insertion, the implant can be continuously expanded, within in the limitations of the design, to the desired height to suit the individual anatomical conditions of the patient. The devices are available in various footprints and geometric options to fit the anatomical needs of a wide variety of patients. The implants include an opening through the superior and inferior endplates of the device to facilitate fusion. The posterior opening of the device allows for the packing of autogenous bone graft material post expansion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

When used as a lumbar intervertebral body fusion device, the Zavation Ti3Z Interbody implants are indicated for spinal fusion procedures to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. For all the above indications the Zavation Ti3Z Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System.

The Zavation Ti3Z Lumbar Interbody System implants are offered in five main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF with the choice of two different material options, allowing for multiple surgical technique options. Ti3Z Lumbar implants are additively manufactured from medical grade Ti64ELI powder by way of laser sintering (ASTM F3001); Ti3Z-PEEK Lumbar implants have an exterior that is manufactured from medical grade PEEK (polyethetherketone) with tantalum beads or pins embedded in the implants to allow for radiographic visualization. Ti3Z-PEEK implants also contain an interior titanium insert manufactured by way of laser sintering (ASTM F3001). The ends of the Ti3Z-PEEK implants have machined teeth which are designed to engage with the vertebral body end plates. The Zavation Ti3Z Lumbar Interbody implants are available in a range of heights, widths, and lengths as well as parallel and lordotic angled implants, to accommodate variations in patient's anatomy. The internal body of the implants have a porous structure wile the external edges of the implants have a solid, roughened surface designed to engage with the vertebral body end plates. All implants will be provided sterile.

The Nisus Touch Negative Pressure Wound Therapy Pump is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.

Cork Medical Products has developed a negative pressure wound therapy pump with the same intended use as its predicate device (K140022) but has the addition of an integrated touch screen. The Nisus Touch and Nisus pumps are nearly identical in appearance and utilize the same buttons to power the device and adjust pump settings; however, the Nisus Touch offers the alternative touch screen to easily maneuver between settings based on operator preference. Visual and audible alarms are consistent with the predicate device K140022 and alert the user when critical battery, pressure leakage, system blockage, and full canister occurs. Additionally, the Nisus Touch mechanical components and therapy application are identical to the Nisus pump. The intent of the new model is to appeal to users who encounter touch screens in daily technology and might feel navigation by touch screen is more simplistic. The components included within the Cork Nisus Touch NPWT Pump are: - Nisus Touch Negative Pressure Wound Therapy Pump - Nisus Touch Pump Battery Charger Accessory components are required to operate the device. Iniection molded components are sonically welded to form a canister designed to mate with the pump and collect excess exudates, infectious material, and tissue debris. The canister design was previously provided clearance within the Nisus NPWT system 510k application (K140022). The Wound Kit comes in multiple iterations containing a minimum of one port pad, wound foam and peel and stick drape. These components are used in coniunction with the pump to ensure safe transfer of the wound debris to the canister. The NPWT Accessories were previously provided clearance on K132004. Our application for the Nisus Touch NPWT system includes no revisions to these previously cleared components.