Australia TGA ARTG record

Actifuse Shape - Bone matrix implant, artificial

Australia TGA ARTG Registered Device · Baxter Healthcare Pty Ltd · Apatech Limited · Class III · Started December 12, 2012

Good Name: Baxter Healthcare Pty Ltd - Actifuse Shape - Bone matrix implant, artificial

Device classification

Risk Class: Class III
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 12, 2012
Effective Date: December 12, 2012

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

Bone graft substitutes are intended to be used in place of cortico-cancellous or cancellous allograft or autograft bone. The mechanical environment for such uses experience either low load requirements or compression. Typical surgical applications for bone graft substitutes are: Small void filling, e.g. after removal of a small bone tumour or following bone fracture reduction or in osteotomies; Spinal fusion, where a cage or screw fixation device is used to relieve the graft site from physiological loads. It is not intended to be used in place of cortical strut allograft bone where high tensile, torsion and/or bending strength are required. The products are used by orthopaedic surgeons in place of allograft bone (bone from humans stored in bone banks).

About this record

Access comprehensive regulatory information for Actifuse Shape - Bone matrix implant, artificial 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 December 12, 2012.

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.