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Surgical planning/navigation-enhancement system

Access comprehensive regulatory information for Surgical planning/navigation-enhancement system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Stryker Australia Pty Ltd, manufactured by Stryker Leibinger GmbH & Co KG in Germany. The device registration started on May 08, 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 IIa
Class IIa
Surgical planning/navigation-enhancement system
Australia TGA ARTG Registered Device
Good Name: Stryker Australia Pty Ltd - Surgical planning/navigation-enhancement system
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Intended Purpose

Intended to be used as a planning and intraoperative guidance system to enable open computer-assisted surgery. Can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 08, 2024
Effective Date
May 08, 2024
Manufacturer
Country
Germany
Address
Botzinger Strasse 41, Freiburg, 79111