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Stereotactic surgery system, orthopaedic - ARTG 371432

Access comprehensive regulatory information for Stereotactic surgery system, orthopaedic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Im is registered under ARTG number 371432 and sponsored by Mathys Orthopaedics Pty Ltd, manufactured by PIXEE MEDICAL in France. The device registration started on July 21, 2021.

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 Im
ARTG 371432
Class Im
Stereotactic surgery system, orthopaedic
ARTG ID: 371432
Good Name: Mathys Orthopaedics Pty Ltd - Stereotactic surgery system, orthopaedic
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Intended Purpose

Knee+ software is intended for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting guide regarding computed mechanical axis.

Device Classification
Risk Class
Class Im
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
371432
Start Date
July 21, 2021
Effective Date
July 21, 2021
Manufacturer
Country
France
Address
18 rue Alain Savary, Besancon, 25000