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Mechanical-resistance external knee prosthesis - ARTG 462391

Access comprehensive regulatory information for Mechanical-resistance external knee prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 462391 and sponsored by Ossur Australia Pty Ltd, manufactured by College Park Industries Inc in United States of America. The device registration started on September 19, 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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TGA ARTG Official Data
Class I
ARTG 462391
Class I
Mechanical-resistance external knee prosthesis
ARTG ID: 462391
Good Name: Ossur Australia Pty Ltd - Mechanical-resistance external knee prosthesis
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Intended Purpose

The device is intended for transfemoral amputees and is designed to restore some function of an anatomical knee joint.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
462391
Start Date
September 19, 2024
Effective Date
September 19, 2024
Manufacturer
Country
United States of America
Address
27955 College Park Drive, Warren, MI, 48088-4877