Australia TGA ARTG record

Turon to RSP Conversion Module - Reverse shoulder prosthesis

Australia TGA ARTG Registered Device · Mathys Orthopaedics Pty Ltd · Encore Medical LP · Class III · Started May 07, 2018

Good Name: Mathys Orthopaedics Pty Ltd - Turon to RSP Conversion Module - Reverse shoulder prosthesis

Device classification

Risk Class: Class III
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 07, 2018
Effective Date: May 07, 2018

Sponsor

Name: Mathys Orthopaedics Pty Ltd

Manufacturer

Name: Encore Medical LP
Country: United States of America
Address: 9800 Metric Boulevard, Austin, TX, 78758-5445

Intended purpose

The Reverse Humeral Socket Shell (Turon to RSP Conversion Shell) is indicated for revision surgeries in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. 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. The socket shell is only indicated for use with a well fixed Turon Humeral Stem.

About this record

Access comprehensive regulatory information for Turon to RSP Conversion Module - Reverse shoulder prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Mathys Orthopaedics Pty Ltd, manufactured by Encore Medical LP in United States of America. The device registration started on May 07, 2018.

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.