Australia TGA ARTG record

Surgical planning/navigation-enhancement system

Australia TGA ARTG Registered Device · Stryker Australia Pty Ltd · Stryker Leibinger GmbH & Co KG · Class IIa · Started May 08, 2024

Good Name: Stryker Australia Pty Ltd - Surgical planning/navigation-enhancement system

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

Sponsor

Name: Stryker Australia Pty Ltd

Manufacturer

Name: Stryker Leibinger GmbH & Co KG
Country: Germany
Address: Botzinger Strasse 41, Freiburg, 79111

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.

About this record

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.