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Gemmed® pedicle screw spinal system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-Sl vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fision. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The spinal system consists of pedicle screws, fixed screws, bars and crosslink rod etc. It is made of titanium alloy (Ti6Al4V ELI), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10th by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.