Australia TGA ARTG recordBIOLOX FORTE Alumina Femoral Head, Taper 12/14 - Ceramic femoral head prosthesis
Australia TGA ARTG Registered Device · Perios Pty Ltd · FH Industrie · Class III · Started February 03, 2018
Good Name: Perios Pty Ltd - BIOLOX FORTE Alumina Femoral Head, Taper 12/14 - Ceramic femoral head prosthesis
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- February 03, 2018
- Effective Date
- February 03, 2018
- Name
- Perios Pty Ltd
- Name
- FH Industrie
- Country
- France
- Address
- 6 Rue Nobel, Z.I. de Kernevez, QUIMPER, 29000
The Biolox Forte Alumina Femoral Head is a sterile prosthetic component designed for first line use, or revision surgery to restore joint function and withstand the usual stresses associated with the hip joint. The prostheses from FH Orthopaedics are indicated for use in o Primary, dysplasic or protruding coxarthrosis o Rheumatoid coxitis o Coxarthritis with necrosis of the femoral head o Revision surgery in a septic or aseptic environment o Congenital dislocation o Traumatic injuries o Femoral neck fracture o Osteonecrosis of the femoral head.
Access comprehensive regulatory information for BIOLOX FORTE Alumina Femoral Head, Taper 12/14 - Ceramic femoral head prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Perios Pty Ltd, manufactured by FH Industrie in France. The device registration started on February 03, 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.