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Anatomical Shoulder Inverse/Reverse Humeral PE-Inlay - Prosthesis, internal, joint, shoulder, humeral component - ARTG 275660

Access comprehensive regulatory information for Anatomical Shoulder Inverse/Reverse Humeral PE-Inlay - Prosthesis, internal, joint, shoulder, humeral component in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 275660 and sponsored by Zimmer Biomet Pty Ltd, manufactured by Zimmer GmbH in Switzerland. The device registration started on May 20, 2016.

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 275660
Class III
Anatomical Shoulder Inverse/Reverse Humeral PE-Inlay - Prosthesis, internal, joint, shoulder, humeral component
ARTG ID: 275660
Good Name: Zimmer Biomet Pty LtdPty Ltd - Anatomical Shoulder Inverse/Reverse Humeral PE-Inlay - Prosthesis, internal, joint, shoulder, humeral component
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Intended Purpose

The AS Inverse/Reverse Humeral PE-Inlay is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The patientโ€™s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
275660
Start Date
May 20, 2016
Effective Date
May 20, 2016
Manufacturer
Country
Switzerland
Address
Sulzerallee 8, Winterthur, 8404