Actifuse Shape - Bone matrix implant, artificial - ARTG 203922
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 registered under ARTG number 203922 and 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.
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).