Device Dossier

Surgical procedure kit, orthopaedic, reusable

Device Dossier for Surgical procedure kit, orthopaedic, reusable (Surgical procedure kit, orthopaedic, reusable, Class IIa, sponsor Zimmer Biomet). ARTG…

Intended purpose

A collection of various surgical instruments, dressings and the necessary materials to perform an orthopaedic surgical procedure. This device can be presented as a kit, tray or set. The contents may include for example, trial prosthetic devices, reamers and other instruments. It is reusable after the appropriate cleaning/sterilizing of the instruments/reusable products and any consumable products have been replenished.

TGA Public Summary