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Stereotactic surgery system, orthopaedic

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.

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Class Im
Class Im
Stereotactic surgery system, orthopaedic
Australia TGA ARTG Registered Device
Good Name: Orthotech Pty Ltd - Stereotactic surgery system, orthopaedic
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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.

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
Manufacturer
Country
United States of America
Address
120 Columbia Suite 500, Aliso Viejo, CA, 92656