NUVASIVE, INCORPORATED
The NuVasive CoRoent Thoracolumbar Implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation system 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 device is indicated for: 1) Thoracic Spine: intended for thoracic interbody fusions at one or two contiguous levels (T1-T2 to T11-T12, or T12-L1) for symptomatic disc degeneration. 2) Lumbar Spine: intended for use at one or two contiguous levels (L1-L2 to L5-S1) for DDD with up to Grade I spondylolisthesis. 3) Partial Vertebral Body Replacement: indicated for use in thoracolumbar spine (T1 to L5) to replace diseased or damaged vertebral body.