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BioBall Head Adaptor - Femoral head/stem prosthesis adaptor

Access comprehensive regulatory information for BioBall Head Adaptor - Femoral head/stem prosthesis adaptor 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 June 08, 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
BioBall Head Adaptor - Femoral head/stem prosthesis adaptor
Australia TGA ARTG Registered Device
Good Name: Corin Australia Pty Ltd - BioBall Head Adaptor - Femoral head/stem prosthesis adaptor
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Intended Purpose

The BioBallโ„ข Head Adaptor 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 - Intraโ€operative correction of offset, neck length, lateralization and anteversion/retroversion with anchored prosthesis stem, and - 12/14 Adapter: Intra-operative correction of offset, neck length, lateralization and anteversion/retroversion during primary operation as well

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 08, 2016
Effective Date
June 08, 2016
Manufacturer
Country
Germany
Address
Alt-Lankwitz 102, Berlin, Germany, 12247