ARTG 300743Stereotactic surgery system, orthopaedic
ARTG ID: 300743 · Amplitude Australia Pty Ltd · Orthalign Inc · Class Im · Started March 13, 2018
Good Name: Amplitude Australia Pty Ltd - Stereotactic surgery system, orthopaedic
- Risk Class
- Class Im
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 300743
- Start Date
- March 13, 2018
- Effective Date
- March 13, 2018
- Name
- Orthalign Inc
- Country
- United States of America
- Address
- 120 Columbia Suite 500, Aliso Viejo, CA, 92656
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
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 registered under ARTG number 300743 and 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.