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Driver, prosthesis - ARTG 371050

Access comprehensive regulatory information for Driver, prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 371050 and sponsored by Optimized Ortho Pty Ltd, manufactured by Global Manufacturing Technology Pty Ltd in Australia. The device registration started on July 14, 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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TGA ARTG Official Data
Class IIa
ARTG 371050
Class IIa
Driver, prosthesis
ARTG ID: 371050
Good Name: Optimized Ortho Pty Ltd - Driver, prosthesis
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Intended Purpose

The instrument is intended to be used to drill a pin, screw or similar into bone as part of an orthopaedic surgery. The proximal end connects to a drill and the distal end connects to a drive feature on the pin or screw to be inserted. It is a reusable device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
371050
Start Date
July 14, 2021
Effective Date
July 14, 2021
Manufacturer
Country
Australia
Address
17 Bridge Street, Pymble, NSW, 2073