Device Dossier

Fixation device, external, system

Device Dossier for Fixation device, external, system (Fixation device, external, system, Class IIb, sponsor DePuy Synthes). ARTG record, intended…

Intended purpose

A system that consists of cases and trays and includes a number of implants, e.g. Steinmann pins, Shanz screws, or Kirschner wires, together with the appropriate instrumentation. The system is designed for a specific procedure, e.g. fracture, spinal or corrective surgery. The implant devices are replaced at intervals when employed to maintain the system. This system is for single-use only.

TGA Public Summary