ARTG 233982B-TCP Gel (GelOS) - Bone matrix implant, synthetic
ARTG ID: 233982 · Pureplay Orthopaedics · TCM Associates Limited · Class III · Started February 17, 2015
Good Name: Pureplay Orthopaedics - B-TCP Gel (GelOS) - Bone matrix implant, synthetic
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 233982
- Start Date
- February 17, 2015
- Effective Date
- February 17, 2015
- Country
- United Kingdom
- Address
- 3 Hillgrove Business Park Nazeing Road, Nazeing, Essex, EN9 2HB
GelOS is intended to be used as a synthetic bone void filler. It is only indicated for filling and/or augmenting bony voids or gaps that are not intrinsic to the stability of the bone structure i.e. subjected to either low load or compressive loading. If osseous defects are intrinsic to the stability and integrity of the skeleton, mechanical stability must be addressed prior to use.
Access comprehensive regulatory information for B-TCP Gel (GelOS) - Bone matrix implant, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 233982 and sponsored by Pureplay Orthopaedics, manufactured by TCM Associates Limited in United Kingdom. The device registration started on February 17, 2015.
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.