ARTG 312503BalanSys UNI vitamys Inlay Fix - Unicondylar knee prosthesis
ARTG ID: 312503 · Mathys Orthopaedics Pty Ltd · Mathys Ltd Bettlach · Class III · Started December 14, 2018
Good Name: Mathys Orthopaedics Pty Ltd - BalanSys UNI vitamys Inlay Fix - Unicondylar knee prosthesis
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 312503
- Start Date
- December 14, 2018
- Effective Date
- December 14, 2018
- Country
- Switzerland
- Address
- Robert Mathys Strasse 5 Bettlach, 2544
The balanSys UNI fixed vitamys inlay forms part of the balanSys UNI knee system that is intended for treating unicompartmental degenerative joint diseases in the medial or lateral femorotibial compartment in skeletally mature patients. Indications for use include painful and / or disabling unicompartmental joint disease in the femorotibial compartment resulting from osteoarthritis, avascular necrosis, or post-traumatic arthritis.
Access comprehensive regulatory information for BalanSys UNI vitamys Inlay Fix - Unicondylar knee prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 312503 and sponsored by Mathys Orthopaedics Pty Ltd, manufactured by Mathys Ltd Bettlach in Switzerland. The device registration started on December 14, 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.