KH075

The CARMEN anterior cervical cage component is intended to be used for anterior cervical inter-body fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral end-plates producing symptomatic nerve root and/or spinal cord compression confirmed by radio-graphic studies. This cage is to be used in patients who have had six weeks of non-operative treatment. The CARMEN cage must be used with supplemental fixation. The Carmen cage is also required to be used with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach