Bone-screw internal spinal fixation system, non-sterile

Intended purpose

Intended for percutaneous, posterior, noncervical pedicle and nonpedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e.,scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.