Pure Global

Bone matrix implant, synthetic

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
Class I
Bone matrix implant, synthetic
Australia TGA ARTG Registered Device
Good Name: Baxter Healthcare Pty Ltd - Bone matrix implant, synthetic
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

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
Manufacturer
Country
United Kingdom
Address
360 Centennial Avenue Centennial Park, Elstree, Hertfordshire, WD6 3TJ