Custom-made anatomy model
Access comprehensive regulatory information for Custom-made anatomy model in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Medacta Australia Pty Ltd, manufactured by Medacta International SA in Switzerland. The device registration started on February 26, 2024.
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.
Devices intended to be used intra-operatively to assist in the positioning of the MySolutions Patient- Matched Guides and in guiding the marking of bone according to the preoperative plan that the surgeon prepared in advance following the Medacta MySolutions process. The bone models are specific for a single patient anatomy and intended for single use only.