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1. Spondylolisthesis Spinal Fixation Device System, 87MNH the intended use and indications for use are: The HAIDER-UCR Spinal System is a pedicle screw system indicated for the . treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. 2. Pedicle Screw Spinal System, (Class II uses) 87MNI the intended use and indications for use are: . The HAIDER-UCR Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: - degenerative with objective evidence of neurological ● spondylolisthesis impairment, - . fracture, - dislocation, ● - scoliosis, . - kyphosis. - spinal tumor, and ● - failed previous fusion pseudarthrosis). .

The HAIDER-UCR Spinal System is a pedicle screw system. The system components include Titanium Pedicle screws, Pedicle Screw Components (Set Screw, Washer, Cap, Housing), Screw Sub-Assembly, Crosslink (Cross Link Nut, Cross Link Hook, Cross-link Bar), 5.5 mm Titanium Rods, and Accessories (Hex 3mm Screw Driver, Hex 4mm Screw Driver). The system is made from titanium alloy (6Al, 4V, Ti).