Device Dossier

Surgical procedure kit, orthopaedic, reusable

Device Dossier for Surgical procedure kit, orthopaedic, reusable (Surgical procedure kit, orthopaedic, reusable, Class IIb, sponsor Surgical…

Intended purpose

A collection of various surgical instruments intended to be used to perform specific orthopaedic surgical procedures. The instruments are typically provided in a single tray, multiple trays or as a set or kit. The trays may also include a selection of bone screws, supplied as non sterile, which may be used in the procedure. The instruments may be reused after the appropriate cleaning and sterilisation has been performed, and the consumable items have been replaced.

TGA Public Summary