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Arthrex® Univers Revers™ Humeral Insert - Reverse shoulder prosthesis cup - ARTG 481546

Access comprehensive regulatory information for Arthrex® Univers Revers™ Humeral Insert - Reverse shoulder prosthesis cup in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 481546 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.

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TGA ARTG Official Data
Class III
ARTG 481546
Class III
Arthrex® Univers Revers™ Humeral Insert - Reverse shoulder prosthesis cup
ARTG ID: 481546
Good Name: Arthrex Australia Pty Ltd - Arthrex® Univers Revers™ Humeral Insert - Reverse shoulder prosthesis cup
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Intended Purpose

Arthrex® Univers Revers™ Humeral Insert 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.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
481546
Start Date
March 03, 2025
Effective Date
March 03, 2025
Manufacturer
Country
United States of America
Address
1370 Creekside Boulevard, Naples, Florida, 34108-1945