Australia TGA ARTG record

Fixation Nail Intramedullary Arthrodesis - Fixation nail, intramedullary, arthrodesis

Australia TGA ARTG Registered Device · Medical & Optical Instruments Australia Pty Ltd · ExsoMed Corporation · Class IIb · Started January 13, 2023

Good Name: Medical & Optical Instruments Australia Pty Ltd - Fixation Nail Intramedullary Arthrodesis - Fixation nail, intramedullary, arthrodesis

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: January 13, 2023
Effective Date: January 13, 2023

Sponsor

Name: Medical & Optical Instruments Australia Pty Ltd

Manufacturer

Name: ExsoMed Corporation
Country: United States of America
Address: 135 Columbia Suite 201, Aliso Viejo, California, 92656

Intended purpose

A fixation device, when inserted into the intramedullary canal, acts as an immobilization device by holding the ends of a fractured or diseased bone together for the purpose of fusion or arthrodesis in orthopaedic surgery.

About this record

Access comprehensive regulatory information for Fixation Nail Intramedullary Arthrodesis - Fixation nail, intramedullary, arthrodesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Medical & Optical Instruments Australia Pty Ltd, manufactured by ExsoMed Corporation in United States of America. The device registration started on January 13, 2023.

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.