Australia TGA ARTG record

Injectable Bone Substitute - Bone matrix implant, synthetic

Australia TGA ARTG Registered Device · Medacta Australia Pty Ltd · Biomatlante SA ZA les Quatre Nations · Class III · Started June 05, 2018

Good Name: Medacta Australia Pty Ltd - Injectable Bone Substitute - Bone matrix implant, synthetic

Device classification

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

Registration information

Start Date: June 05, 2018
Effective Date: June 05, 2018

Sponsor

Name: Medacta Australia Pty Ltd

Manufacturer

Name: Biomatlante SA ZA les Quatre Nations
Country: France
Address: 5 Rue Edouard Belin, Vigneux de Bretagne, 44360

Intended purpose

In'Oss is intended for use as bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. When packed into a bony site, In'Oss gradually resorbs and is replaced with bone during the healing process.

About this record

Access comprehensive regulatory information for Injectable Bone Substitute - Bone matrix implant, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Medacta Australia Pty Ltd, manufactured by Biomatlante SA ZA les Quatre Nations in France. The device registration started on June 05, 2018.

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.