Australia TGA ARTG record

Orthopaedic prosthesis implantation instrument, reusable

Australia TGA ARTG Registered Device · Zimmer Biomet Pty Ltd · P W Coole & Son Ltd, Trading as Surgical Holdings · Class I · Started May 20, 2019

Good Name: Zimmer Biomet Pty Ltd - Orthopaedic prosthesis implantation instrument, reusable

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 20, 2019
Effective Date: May 20, 2019

Sponsor

Name: Zimmer Biomet Pty Ltd

Manufacturer

Name: P W Coole & Son Ltd, Trading as Surgical Holdings
Country: United Kingdom
Address: Unit 8 Parkside Centre Temple Farm Industrial Estate, Southend on Sea, Essex , SS2 5SJ

Intended purpose

A hand-held surgical instrument intended to be used during an orthopaedic procedure. This is a reusable device.

About this record

Access comprehensive regulatory information for Orthopaedic prosthesis implantation instrument, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Zimmer Biomet Pty Ltd, manufactured by P W Coole & Son Ltd, Trading as Surgical Holdings in United Kingdom. The device registration started on May 20, 2019.

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.