Pure Global

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

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class III
Class III
Axioma TT Baseplate (Ti6Al4V) - Prosthesis, internal, joint, shoulder, glenoid component
Australia TGA ARTG Registered Device
Good Name: Lima Orthopaedics Australia Pty Ltd - Axioma TT Baseplate (Ti6Al4V) - Prosthesis, internal, joint, shoulder, glenoid component
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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 patientโ€™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.

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
Manufacturer
Country
Italy
Address
Via Nazionale 52, San Daniele del Friuli, Frazione Villanova Udine, 33038