Australia TGA ARTG record

Stereotactic surgery system, orthopaedic

Australia TGA ARTG Registered Device · Amplitude Australia Pty Ltd · Orthalign Inc · Class Im · Started March 13, 2018

Good Name: Amplitude Australia Pty Ltd - Stereotactic surgery system, orthopaedic

Device classification

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

Registration information

Start Date: March 13, 2018
Effective Date: March 13, 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

A computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopaedic surgical procedures. Example orthopaedic surgical procedures include but are not limited to: - Total Knee Arthroplasty - Total Hip Arthroplasty - Unicompartmental Knee Arthroplasty

About this record

Access comprehensive regulatory information for Stereotactic surgery system, orthopaedic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Im is sponsored by Amplitude Australia Pty Ltd, manufactured by Orthalign Inc in United States of America. The device registration started on March 13, 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.