ARTG 481545Arthrex® Univers Revers™ Spacer - Reverse shoulder prosthesis body
ARTG ID: 481545 · Arthrex Australia Pty Ltd · Arthrex Inc · Class III · Started March 03, 2025
Good Name: Arthrex Australia Pty Ltd - Arthrex® Univers Revers™ Spacer - Reverse shoulder prosthesis body
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 481545
- Start Date
- March 03, 2025
- Effective Date
- March 03, 2025
- Name
- Arthrex Inc
- Country
- United States of America
- Address
- 1370 Creekside Boulevard, Naples, Florida, 34108-1945
Arthrex® Univers Revers™ Spacer is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. It is indicated for primary or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Access comprehensive regulatory information for Arthrex® Univers Revers™ Spacer - Reverse shoulder prosthesis body in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 481545 and sponsored by Arthrex Australia Pty Ltd, manufactured by Arthrex Inc in United States of America. The device registration started on March 03, 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.