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Custom-made orthopaedic surgical guide, non-sterile - ARTG 442475

Access comprehensive regulatory information for Custom-made orthopaedic surgical guide, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 442475 and sponsored by Medacta Australia Pty Ltd, manufactured by Medacta International SA in Switzerland. The device registration started on February 26, 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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TGA ARTG Official Data
Class IIa
ARTG 442475
Class IIa
Custom-made orthopaedic surgical guide, non-sterile
ARTG ID: 442475
Good Name: Medacta Australia Pty Ltd - Custom-made orthopaedic surgical guide, non-sterile
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Intended Purpose

Devices intended for use as anatomical guides specifically manufactured for the anatomy of a single patient. They are designed for use as a bone marking guide prior to the bone preparation and to assist in the positioning of hip replacement components intra-operatively.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
442475
Start Date
February 26, 2024
Effective Date
February 26, 2024
Manufacturer
Country
Switzerland
Address
Strada Regina, Castel San Pietro, CH-6874