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The VEOS Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine (from T1 to S1). The VEOS Spinal Fixation System is intended for noncervical pedicle fixation for the following indications : degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor: pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the VEOS Spinal Fixation System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, The VEOS Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. Pediatric pedicle screw fixation is limited to a posterior approach. This system is intended to be used with autograft and/or allograft.

The Spineway VEOS Spinal Fixation System is composed of implant devices made from a titanium alloy Ti6Al4V-ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. All implants are provided sterile or non-sterile. The implants are to be implanted from the posterior approach. The screws are available as monoaxial reduction screws in multiple diameters and length. Titanium rods are available in two diameters and multiple lengths. CoCr rods are available in one diameter and two length. CoCr rods are only available non-sterile. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided. Screws for MS applications are available as polyaxial cannulated screws in multiple diameters and lengths. Rods for MS applications are available as pre-bent rods and straight rods. Associated instrumentation to complete the procedure is provided.

The mont blanc system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral/iliac spine. This mont blanc system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) for the following indications in skeletally mature patients: · degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); · spondylolisthesis; - · trauma (i.e., fracture or dislocation); - · spinal stenosis; - · deformities (i.e., scoliosis, kyphosis, and/or lordosis); - · spinal tumor, - · pseudoarthrosis; and - · failed previous fusion. The mont blanc system is intended to be used with autograft and/or allograft. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc and Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The mont blanc MIS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. This mont blanc MIS system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) utilizing a percutaneous minimally approach for the following indications in skeletally mature patients: · degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); · spondylolisthesis; - · trauma (i.e., fracture or dislocation); - · spinal stenosis; - · deformities (i.e., scoliosis, kyphosis, and/or lordosis); - · spinal tumor, - · pseudoarthrosis; and - · failed previous fusion. The mont blanc MIS system is intended to be used with autograft and/or allograft. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograff. Pediatric pedicle screw fixation is limited to a posterior approach.

The Spineway mont blanc & mont blanc MIS Spinal Systems are implant device systems comprised of a titanium alloy Ti 6Al-4V ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. The fenestrated screws are polyaxial screws in diameters from 5.0 – 8.0 mm and in lengths from 30 – 55 mm. 6 fenestration holes are present in screws of length 35 mm or longer, 3 fenestration holes are present in screws of length 30 mm. Dual connectors and domino connectors are available to connect 2 parallel rods together, lliac lateral connectors are available to create an Iliac fixation, and Axial connectors are available to connect 2 coaxial rods together. Associated instrumentation to complete the procedure is provided reusable and non-sterile.

The Ayers Rock Cervical interbody fusion system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Ayers Rock Cervical interbody fusion devices are to be used with autogenous bone graft and implanted via an open, anterior approach. The Ayers Rock Cervical interbody fusion system is to be used with supplemental fixation.

The Avers Rock Cervical interbody fusion system consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Ayers Rock Cervical interbody fusion system is manufactured from PEEK-OPTIMA® LT1 polymer and contains tantalum radiopaque markers. The Ayers Rock Cervical interbody fusion system is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.

The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine and sacral/iliac screw fixation. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the Mont Blanc MIS System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft. Pediatric pediale screw fixation is limited to a posterior approach.

The Spineway Mont Blanc and Mont Blanc MIS Spinal Systems are composed of implant device made from a titanium alloy Ti6Al4V-ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. All implant components are provided sterile. It is to be implanted from the posterior approach. The screws are available as monobloc and monobloc reduction (traction) screws and polyaxial reduction (traction) screws in diameters from 4.0-8.0 mm and in lengths from 25-55 mm and polyaxial iliac screws of 7 and 8mm diameters with lengths from 55mm to 110mm. Rods are available in 5.5mm diameter in lengths from 40-500 mm. Hooks are available in various sizes to attach to the thoracic and lumbar spine. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided. Screws for MIS applications are available as polyaxial cannulated screws in diameter from 4.5-8mm and in lengths from 25-60mm. Rods for MIS applications are available as 5.5mm pre-bent rods from 50-140mm and straight rods from 50-500mm.

The Twin Peaks Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Twin Peaks System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Twin Peaks System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

The Twin Peaks Lumbar Interbody Fusion System consist of 3 designs, PLIF & PLIF BS, TLIF and OLIF. The PLIF and TLIF implants are available as a lordotic form, while the OLIF implants are provided with no lordosis. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Two radiographic markers made of tantalum per ASTM F560 are included in the PLIF and OLIF PEEK implants, and three radiographic markers made of tantalum per ASTM F560 are included in the TLIF PEEK implant to allow radiographic visualization.

The Mout Blanc Spinal System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae and sacral/iliac screw fixation in skeletally mature patients as an adjunct to fission for the following indications: degenerative disc disease (defined as back pain of discogence origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Spineway Mont Blanc Spinal System is an implant device made from a titanium alloy TI 6Al 4V-ELI. It is to be implanted from the posterior approach. The screws are available as monobloc and monobloc reduction (traction) screws and polyaxial reduction (traction) screws in diameters from 4.0-8.0 mm and in lengths from 25-55 mm and polyaxial iliac screws of 7 and 8mm diameters with lengths from 55mm to 110mm. Rods are available in 5.5mm diameter in lengths from 40-500 mm. Hooks are available in various sizes to attach to the thoracic and lumbar spine. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided.

The Spineway Blue Mountain Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Spineway Blue Mountain Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions. This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

The Spineway Blue Mountain Cervical Plate System that includes titanium alloy (per ASTM F136 and ISO 5832-3) plates and screws that are intended to stabilize the spine during the fusion process. The plates and screws are available in various sizes to accommodate patients' anatomy. The plates are contoured to follow the curves of the cervical spine.