ARTG 193684Actifuse MIS Bone Graft Substitute - Bone matrix implant, artificial
ARTG ID: 193684 · Baxter Healthcare Pty Ltd · Apatech Limited · Class III · Started January 11, 2012
Good Name: Baxter Healthcare Pty Ltd - Actifuse MIS Bone Graft Substitute - Bone matrix implant, artificial
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 193684
- Start Date
- January 11, 2012
- Effective Date
- January 11, 2012
- Name
- Apatech Limited
- Country
- United Kingdom
- Address
- 360 Centennial Avenue Centennial Park, Elstree, Hertfordshire, WD6 3TJ
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).
Access comprehensive regulatory information for Actifuse MIS Bone Graft Substitute - 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 193684 and sponsored by Baxter Healthcare Pty Ltd, manufactured by Apatech Limited in United Kingdom. The device registration started on January 11, 2012.
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