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Reverse shoulder prosthesis

Access comprehensive regulatory information for Reverse shoulder prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Signature Orthopaedics Pty Ltd, manufactured by Signature Orthopaedics Pty Ltd in Australia. The device registration started on March 25, 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
Class I
Reverse shoulder prosthesis
Australia TGA ARTG Registered Device
Good Name: Signature Orthopaedics Pty Ltd - Reverse shoulder prosthesis
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Intended Purpose

The device is intended for use in a reverse shoulder joint replacement. The device is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The device is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
Start Date
March 25, 2024
Effective Date
March 25, 2024
Manufacturer
Country
Australia
Address
7 Sirius Road, LANE COVE WEST, NSW, 2066