Australia TGA ARTG recordInductigraft - Bone matrix implant, synthetic
Australia TGA ARTG Registered Device · Baxter Healthcare Pty Ltd · Apatech Limited · Class III · Started January 10, 2023
Good Name: Baxter Healthcare Pty Ltd - Inductigraft - Bone matrix implant, synthetic
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- January 10, 2023
- Effective Date
- January 10, 2023
- Name
- Apatech Limited
- Country
- United Kingdom
- Address
- 360 Centennial Avenue Centennial Park, Elstree, Hertfordshire, WD6 3TJ
The Inductigraft bone graft substitute is indicated to be used in place of corticocancellous, or cancellous allograft or autograft bone in mechanical environments which experience either low load requirements or compression. • Surgical applications for the Inductigraft bone graft substitute are: - Spinal fusion, e.g. posterolateral spinal and interbody fusions, where appropriate hardware such as pedicle screws or an interbody cage device is used to relieve the graft site from physiological loads, • It is not indicated to be used in place of cortical strut allograft bone where high tensile, torsion and/or bending strength are required
Access comprehensive regulatory information for Inductigraft - Bone matrix implant, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Baxter Healthcare Pty Ltd, manufactured by Apatech Limited in United Kingdom. The device registration started on January 10, 2023.
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.