Device Category Dossier

Fixation system implantation kit, internal

Device Category Dossier for Fixation system implantation kit, internal. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Orthopaedic fixation instrument kits comprise collections of metallic and plastic reusable devices such as retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, and impactors intended for placement of internal orthopaedic fixation systems into or onto bones throughout the body including limbs, spine, pelvis, and craniomaxillofacial structures, with the actual implants supplied separately. These instruments are used clinically for orthopaedic extremity treatment of fractures, fusions, osteotomies, arthrodesis of small joints and joint instability.