Orthopaedic prosthesis implantation instrument, reusable
Access comprehensive regulatory information for Orthopaedic prosthesis implantation instrument, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Zimmer Biomet Pty Ltd, manufactured by Biomet Trauma in United States of America. The device registration started on December 17, 2018.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.