Australia TGA ARTG record

Stereotactic surgery system, orthopaedic

Australia TGA ARTG Registered Device · Orthotech Pty Ltd · Orthalign Inc · Class Im · Started April 30, 2021

Good Name: Orthotech Pty Ltd - Stereotactic surgery system, orthopaedic

Device classification

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

Registration information

Start Date: April 30, 2021
Effective Date: April 30, 2021

Sponsor

Name: Orthotech Pty Ltd

Manufacturer

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

Intended purpose

The OrthAlign Plus Navigation Unit is a single use sterile component of the OrthAlign Plus System which is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus System facilitates the accurate positioning of implants, relative to these alignment axes.

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 Orthotech Pty Ltd, manufactured by Orthalign Inc in United States of America. The device registration started on April 30, 2021.

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.