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1.5mm Bone Fixation Kit - Surgical procedure kit, arthroscopic, single-use, non-medicated

Access comprehensive regulatory information for 1.5mm Bone Fixation Kit - Surgical procedure kit, arthroscopic, single-use, non-medicated in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by ConMed Linvatec Australia Pty Ltd, manufactured by ConMed Corporation in United States of America. The device registration started on June 21, 2023.

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 III
Class III
1.5mm Bone Fixation Kit - Surgical procedure kit, arthroscopic, single-use, non-medicated
Australia TGA ARTG Registered Device
Good Name: ConMed Linvatec Australia Pty Ltd - 1.5mm Bone Fixation Kit - Surgical procedure kit, arthroscopic, single-use, non-medicated
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Intended Purpose

The SmartNailยฎ Bone Fixation Kit is presented as a sterile, single-use kit intended for use in the fixation of fragments of fractured non-load bearing bones, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments in the presence of appropriate brace and/or immobilisation.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 21, 2023
Effective Date
June 21, 2023
Manufacturer
Country
United States of America
Address
525 French Road, Utica, New York, 13502