Australia TGA ARTG record

Surgical procedure kit, orthopaedic, single-use, non-medicated

Australia TGA ARTG Registered Device · Amplitude Australia Pty Ltd · Orthalign Inc · Class I · Started March 23, 2018

Good Name: Amplitude Australia Pty Ltd - Surgical procedure kit, orthopaedic, single-use, non-medicated

Device classification

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

Registration information

Start Date: March 23, 2018
Effective Date: March 23, 2018

Sponsor

Name: Amplitude Australia Pty Ltd

Manufacturer

Name: Orthalign Inc
Country: United States of America
Address: 120 Columbia Suite 500, Aliso Viejo, CA, 92656

Intended purpose

Resusable instrument kit to be use with OrthAlign PLUS for use in surgical procedures

About this record

Access comprehensive regulatory information for Surgical procedure kit, orthopaedic, single-use, non-medicated in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Amplitude Australia Pty Ltd, manufactured by Orthalign Inc in United States of America. The device registration started on March 23, 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.