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The BioBall Metal Head Vivium - Metallic femoral head prosthesis

Access comprehensive regulatory information for The BioBall Metal Head Vivium - Metallic femoral head prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Corin Australia Pty Ltd, manufactured by Merete GmbH in Germany. The device registration started on December 22, 2015.

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
The BioBall Metal Head Vivium - Metallic femoral head prosthesis
Australia TGA ARTG Registered Device
Good Name: Corin Australia Pty Ltd - The BioBall Metal Head Vivium - Metallic femoral head prosthesis
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Intended Purpose

The BioBallโ„ข Metal Head Vivium is part of the BioBallโ„ข System which is designed for use in either primary or revision hip arthroplasty. It is intended to be used in the following indications: - Sliding pair revisions; and - Intra?operative correction of offset, neck length, lateralization and anteversion/retroversion with anchored prosthesis stem.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 22, 2015
Effective Date
December 22, 2015
Manufacturer
Country
Germany
Address
Alt-Lankwitz 102, Berlin, Germany, 12247