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MEDPOR Customized Cranial Implant - Prosthesis, internal, ear/nose/throat, synthetic - ARTG 434590

Access comprehensive regulatory information for MEDPOR Customized Cranial Implant - Prosthesis, internal, ear/nose/throat, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 434590 and sponsored by Stryker Australia Pty Ltd, manufactured by Stryker Leibinger GmbH & Co KG in Germany. The device registration started on January 17, 2024.

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
ARTG 434590
Class III
MEDPOR Customized Cranial Implant - Prosthesis, internal, ear/nose/throat, synthetic
ARTG ID: 434590
Good Name: Stryker Australia Pty Ltd - MEDPOR Customized Cranial Implant - Prosthesis, internal, ear/nose/throat, synthetic
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Intended Purpose

The MEDPOR Customized Implant is indicated for the augmentation and/or restoration of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects, including, but not limited to, the correction and prevention of persistent temporal hollowing (PTH), in the adult population.

Device Classification
Risk Class
Class III
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
434590
Start Date
January 17, 2024
Effective Date
January 17, 2024
Manufacturer
Country
Germany
Address
Botzinger Strasse 41, Freiburg, 79111