NUVASIVE, INCORPORATED
The NuVasive CoRoent System is 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 lumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent System (L and XL platforms) are intended for use at either one level or two contiguous levels in the lumbar spine, from L1-L2 to L5-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. Additionally, the CoRoent System (L and XL platforms) can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.