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The intended use of the CurvTek TSR System is substantially equivalent to the predicate devices listed in this 510(k) application. The device is to be used to drill holes in bone, except for cranio and maxifacial bones, for soft tissue attachment, or wiring/cabling as in the following techniques: Soft Tissue Repair Techniques (Shoulder, Hip, Elbow, Knee, Limb Salvage, Hand and Wrist, Foot & Ankle, Urological) and Wiring/Cabling Techniques (Cervical Cabling, Lumbar Cabling, Osteotomy of Cervical Spine, Arthrodesis, Lateral Transverse Process, Trauma).

The CurvTek TSR System is a pneumatically powered instrument system consisting of a handpiece, disposable single patient use drill bit cartridges, and 510(k) approved accessories. Accessories include Zimmer® (Hall®) style nitrogen hose and sterilization container system.