Pure Global

Driver, prosthesis - ARTG 384792

Access comprehensive regulatory information for Driver, prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 384792 and sponsored by Zimmer Biomet Pty Ltd, manufactured by Biomet Orthopedics in United States of America. The device registration started on February 28, 2022.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 384792
Class I
Driver, prosthesis
ARTG ID: 384792
Good Name: Zimmer Biomet Pty Ltd - Driver, prosthesis
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

A hand-held manual surgical instrument designed to impart force to an orthopaedic device that is inserted to fix or fasten together bones. The device is used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
384792
Start Date
February 28, 2022
Effective Date
February 28, 2022
Manufacturer
Country
United States of America
Address
56 East Bell Drive, Airport Industrial Park, Warsaw, IN, 46581