RSP Humeral Socket Insert E+ - Reverse shoulder prosthesis cup - ARTG 400333
Access comprehensive regulatory information for RSP Humeral Socket Insert E+ - 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 400333 and sponsored by Mathys Orthopaedics Pty Ltd, manufactured by Encore Medical LP in United States of America. The device registration started on November 29, 2022.
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.
A component of a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: - Severe arthropathy with a grossly deficient rotator cuff; - Previously failed joint replacement with a grossly deficient rotator cuff; - Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; - Bone defect in proximal humerus; - Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; - Inflammatory arthritis including rheumatoid arthritis; - Correction of functional deformity.