Australia TGA ARTG record

GMT Global Ceramic Head - Ceramic femoral head prosthesis

Australia TGA ARTG Registered Device · Corin Australia Pty Ltd · Global Manufacturing Technology Pty Ltd · Class III · Started June 26, 2018

Good Name: Corin Australia Pty Ltd - GMT Global Ceramic Head - Ceramic femoral head prosthesis

Device classification

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

Registration information

Start Date: June 26, 2018
Effective Date: June 26, 2018

Sponsor

Name: Corin Australia Pty Ltd

Manufacturer

Name: Global Manufacturing Technology Pty Ltd
Country: Australia
Address: 17 Bridge Street, Pymble, NSW, 2073

Intended purpose

The device is a ceramic femoral head used as the replacement of a diseased or damaged femoral head in total hip arthroplasty, or to revise a previously implanted prosthesis. The device is intended to be attached to the trunnion of a femoral stem prosthesis, and articulate with the acetabulum, or inner surface of an acetabular prosthesis. It is supplied sterile, and is intended for single use only.

About this record

Access comprehensive regulatory information for GMT Global Ceramic Head - Ceramic femoral head prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Corin Australia Pty Ltd, manufactured by Global Manufacturing Technology Pty Ltd in Australia. The device registration started on June 26, 2018.

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.