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RSP Humeral Stem Adapter - Reverse shoulder prosthesis

Access comprehensive regulatory information for RSP Humeral Stem Adapter - 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.

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TGA ARTG Official Data
Class III
Class III
RSP Humeral Stem Adapter - Reverse shoulder prosthesis
Australia TGA ARTG Registered Device
Good Name: Mathys Orthopaedics Pty Ltd - RSP Humeral Stem Adapter - Reverse shoulder prosthesis
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Intended Purpose

During primary surgery, after the humerus is prepared for the RSP® humeral stem, if the glenoid bone stock appears “insufficient” to bear the load of the glenoid baseplate, a RSP® humeral stem adapter can be used to convert the RSP® humeral stem to hemiarthroplasty prosthesis. During revision surgery of an RSP®, if the glenoid bone stock appears to be “insufficient” to bear the load of the glenoid baseplate, a RSP® humeral stem adapter is used to convert the RSP® device to hemiarthroplasty 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
Manufacturer
Country
United States of America
Address
9800 Metric Boulevard, Austin, TX, 78758-5445