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Axioma TT Baseplate (Ti6Al4V) - Prosthesis, internal, joint, shoulder, glenoid component

Australia TGA ARTG Registered Device · Lima Orthopaedics Australia Pty Ltd · Limacorporate Spa · Class III · Started August 02, 2023

Good Name: Lima Orthopaedics Australia Pty Ltd - Axioma TT Baseplate (Ti6Al4V) - Prosthesis, internal, joint, shoulder, glenoid component

Device classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
August 02, 2023
Effective Date
August 02, 2023
Sponsor
Manufacturer
Country
Italy
Address
Via Nazionale 52, San Daniele del Friuli, Frazione Villanova Udine, 33038
Intended purpose

The SMR AXIOMA TT (L3) Reverse System is indicated for revision total shoulder replacement in grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient’s joint must be anatomically and structurally suited to receive the selected implants and functional deltoid muscle is necessary to use the device. The modular SMR System allows the assembly of components in various humeral and glenoid constructs.

About this record

Access comprehensive regulatory information for Axioma TT Baseplate (Ti6Al4V) - Prosthesis, internal, joint, shoulder, glenoid component in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Lima Orthopaedics Australia Pty Ltd, manufactured by Limacorporate Spa in Italy. The device registration started on August 02, 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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