Device Dossier

Surgical procedure kit, orthopaedic, reusable

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

Intended purpose

A Procedure Pack is a set of orthopaedic instruments located within specially designed instrument trays (procedure packs) that are used to facilitate and assist surgeons in the implantation of medical devices during orthopaedic surgery. An orthopaedic manual surgical instrument is a hand-held device intended for medical purposes to manipulate tissue, assist in inserting the associated implantable device, or guide other instruments such as drills and pins. This generic type of device includes non-sterile devices that are located in instrument trays that consist of instruments including nail holders, awl, retractor, forceps, tissue guard, drill sleeves, screwdrivers and alignment guides .

TGA Public Summary