Device Dossier
Fixation system implantation kit, internal
Device Dossier for Fixation system implantation kit, internal (Fixation system implantation kit, internal, Class IIa, sponsor Osteotomie). ARTG record,…
- GMDN category: Fixation system implantation kit, internal
Intended purpose
A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.