Australia TGA ARTG record

Bone matrix implant, synthetic

Australia TGA ARTG Registered Device · Baxter Healthcare Pty Ltd · Apatech Limited · Class I · Started May 23, 2022

Good Name: Baxter Healthcare Pty Ltd - Bone matrix implant, synthetic

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General-Export

Registration information

Start Date: May 23, 2022
Effective Date: May 23, 2022

Sponsor

Name: Baxter Healthcare Pty Ltd

Manufacturer

Name: Apatech Limited
Country: United Kingdom
Address: 360 Centennial Avenue Centennial Park, Elstree, Hertfordshire, WD6 3TJ

Intended purpose

Inductigraft is a bone graft substitute, 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, - Small void filling, e.g., following bone fracture reduction.

About this record

Access comprehensive regulatory information for Bone matrix implant, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Baxter Healthcare Pty Ltd, manufactured by Apatech Limited in United Kingdom. The device registration started on May 23, 2022.

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.