Australia flagARTG 448066

Surgical planning/navigation-enhancement system

ARTG ID: 448066 · 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
ARTG ID
448066
Start Date
May 08, 2024
Effective Date
May 08, 2024
Sponsor
Manufacturer
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 registered under ARTG number 448066 and 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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