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Stereotactic surgery system, orthopaedic - ARTG 300742

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 300742 and sponsored by Lima Orthopaedics 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.

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Class Im
ARTG 300742
Class Im
Stereotactic surgery system, orthopaedic
ARTG ID: 300742
Good Name: Lima Orthopaedics Australia Pty Ltd - Stereotactic surgery system, orthopaedic
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Intended Purpose

OrthAlign Plus system is 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. The OrthAlign Plus system facilitates the accurate positioning of implants, relative to these alignment axes.

Device Classification
Risk Class
Class Im
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
300742
Start Date
March 13, 2018
Effective Date
March 13, 2018
Manufacturer
Country
United States of America
Address
120 Columbia Suite 500, Aliso Viejo, CA, 92656