Pure Global

UniAlign Instrument Set - Surgical procedure kit, orthopaedic, reusable

Access comprehensive regulatory information for UniAlign Instrument Set - Surgical procedure kit, orthopaedic, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Smith & Nephew Pty Ltd, manufactured by Orthalign Inc in United States of America. The device registration started on April 09, 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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TGA ARTG Official Data
Class I
Class I
UniAlign Instrument Set - Surgical procedure kit, orthopaedic, reusable
Australia TGA ARTG Registered Device
Good Name: Smith & Nephew Pty Ltd - UniAlign Instrument Set - Surgical procedure kit, orthopaedic, reusable
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Intended Purpose

Reusable marker, guides and instruments for a computer assisted surgery device designed to assist a surgeon in the alignment of the cutting guides during unicompartmental knee arthroplasty

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
April 09, 2018
Effective Date
April 09, 2018
Sponsor
Manufacturer
Country
United States of America
Address
120 Columbia Suite 500, Aliso Viejo, CA, 92656