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Endo Model Cementless Cylindrical Stems - Knee stem - ARTG 460131

Access comprehensive regulatory information for Endo Model Cementless Cylindrical Stems - Knee stem in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 460131 and sponsored by Link Orthopaedics Australia Pty Ltd, manufactured by Waldemar Link GmbH & Co KG in Germany. The device registration started on August 20, 2024.

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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Class III
ARTG 460131
Class III
Endo Model Cementless Cylindrical Stems - Knee stem
ARTG ID: 460131
Good Name: Link Orthopaedics Australia Pty Ltd - Endo Model Cementless Cylindrical Stems - Knee stem
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Intended Purpose

Cementless cylindrical stem components of the LinkSymphoKnee and Endo Model systems intended to be used for the long-term replacement of a diseased and / or defective knee joint in the human body. The knee system forms a total replacement of the knee joint when combined with the femoral-, tibial- and polyethylene plateau. Indicationed for any form of uni-, bi- or tricompartimental arthritis of the knee joint (e.g. primary degenerative arthritis/ osteoarthritis, secondary arthritis resulting from rheumatoid arthritis and fracture).

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
460131
Start Date
August 20, 2024
Effective Date
August 20, 2024
Manufacturer
Country
Germany
Address
Barkhausenweg 10, Hamburg, 22339