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Anatomical Shoulder Humeral Fracture Head - Prosthesis, internal, joint, shoulder, humeral component

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

The AS Fracture Head intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasty in treatment of 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment; 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment; 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment; fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus; post-traumatic necrosis of the humeral head; post-traumatic arthrosis after humeral head fracture.

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