Spinal bone screw, non-biodegradable

Intended purpose

Intended for intervertebral screw fixation of the lumbar spine from L2-S1. The Lumbar screws are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.