Device Dossier

Fixation system, internal,fracture, non-biodegradable

Device Dossier for Fixation system, internal,fracture, non-biodegradable (Fixation system, internal,fracture, non-biodegradable, Class IIb, sponsor Life…

Intended purpose

A device designed for the stabilization of fractured bones for an expedient healing process. Consists of a set of metallic plates, screws, wires, and pins for bone fixation made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium (alloy), or carbon fibre). Includes instruments for attaching the implants such as screwdrivers and drills.

TGA Public Summary