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The Baxano Surgical MIS Pedicle Screw System is intended for posterior, non-cervical 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: (1) Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) Spondylolisthesis, (3) Trauma (i.e. fracture or dislocation), (4) Spinal stenosis, (5) Curvatures (i.e. scoliosis, and/or lordosis), (6) Tumor, (7) Pseudoarthrosis and (8) Failed previous fusion.

The Baxano Surgical MIS Pedicle Screw System is a multiple component system comprised of non-sterile, single-use implantable components fabricated from titanium alloy and cobalt chrome. When assembled, the components are implanted via a percutaneous, mini-open or open delivery to create a rigid structure to provide stabilization and promote spinal fusion. The system consists of an assortment of polyaxial cannulated pedicle screws, rods, cross connectors and locking caps, and associated instruments.