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…
- GMDN category: Fixation device, external, system
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. Those external devices within the system may be reused in accordance with the manufacturer's instructions