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The LEGEND Spine CORNICE Cervical Spacer System is indicated for use as an intervertebral body fusion device 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 one or two contiguous levels from C2 to T1. These patients should have had six weeks of non-operative treatment. The LEGEND Spine CORNICE Cervical Spacer System is also to be used with supplemental fixation system that have been cleared for use in the cervical spine. The LEGEND Spine CORNICE Cervical Spacer System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The LEGEND Spine CORNICE Cervical Spacer System is an Anterior Cervical Interbody Fusion Device that has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Legend Spine CORNICE Spacers are made from either PEEK (VESTAKEEP i4 R per ASTM F2026) radiolucent material with embedded tantalum (ASTM F560) x-ray markers or Titanium Alloy conforming to ASTM F136.

The LEGEND Spine STYLO Interbody Fusion Device 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). LEGEND Spine STYLO Interbody Fusion Device is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach. LEGEND Spine STYLO Interbody Fusion Device implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Legend Spine Technologies STYLO Interbody Fusion Device is an Interbody Fusion Device that has a hollow chamber to permit packing with autologous bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Legend Spine Technologies STYLO interbody implants are made from either PEEK radiolucent material with embedded tantalum x-ray markers (ASTM F2026 and ASTM F560) or titanium alloy conforming to ASTM F136.