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Anatomical Shoulder Ball-Taper for Humeral Stems - Prosthesis, internal, joint, shoulder, humeral component

Access comprehensive regulatory information for Anatomical Shoulder Ball-Taper for Humeral Stems - 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 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
Class III
Anatomical Shoulder Ball-Taper for Humeral Stems - Prosthesis, internal, joint, shoulder, humeral component
Australia TGA ARTG Registered Device
Good Name: Zimmer Biomet Pty LtdPty Ltd - Anatomical Shoulder Ball-Taper for Humeral Stems - Prosthesis, internal, joint, shoulder, humeral component
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Intended Purpose

The Ball-taper for Humeral Stems is part of the Anatomical Shoulder system and is indicated for patients with advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis; fractures or avascular necrosis; conditions consequent to earlier operations; omarthrosis; rheumatoid arthritis; revision of shoulder prosthesis; traumatology: the only cone to be used in traumatological indications is the fracture cone.

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