Bone-screw internal spinal fixation system, non-sterile

Intended purpose

Intended for anterior/anterolateral and posterior, pedicle and non-pedicle 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.