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BIOTWIN - Fixation screw, bone, biodegradable - ARTG 482906

Access comprehensive regulatory information for BIOTWIN - Fixation screw, bone, biodegradable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 482906 and sponsored by Compliance Management Solutions, manufactured by Biomatlante SA in France. The device registration started on March 18, 2025.

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.

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TGA ARTG Official Data
Class III
ARTG 482906
Class III
BIOTWIN - Fixation screw, bone, biodegradable
ARTG ID: 482906
Good Name: Compliance Management Solutions - BIOTWIN - Fixation screw, bone, biodegradable
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Intended Purpose

The composite interference screw is intended to be used in knee ligament reconstruction procedures. It ensures the fixation of the transplant within the bone tunnel during the healing period and for a maximum duration of 48 months.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482906
Start Date
March 18, 2025
Effective Date
March 18, 2025
Manufacturer
Country
France
Address
ZA Les Quatre Nations 5 Rue Edouard Belin, Vigneux de Bretagne, 44360