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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the KOBRA™GPS Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the KOBRA™GPS Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The Medtronic Vertelink KOBRA™ GPS Fixation System consists of a variety of cannulated rods and cannulated multi-axial screws used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The KOBRA™ GPS Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The KOBRA™ GPS implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.