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Coated hip femur prosthesis, modular

Access comprehensive regulatory information for Coated hip femur prosthesis, modular in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Signature Orthopaedics Pty Ltd, manufactured by Signature Orthopaedics Europe Ltd in Ireland. The device registration started on September 15, 2021.

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 I
Class I
Coated hip femur prosthesis, modular
Australia TGA ARTG Registered Device
Good Name: Signature Orthopaedics Pty Ltd - Coated hip femur prosthesis, modular
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Intended Purpose

The Signature Orthopaedics Aria Reduced Distal Stem (RDS) is a Ti6Al4V dual-tapered stem with 12/14 style morse taper connection used in total hip arthroplasty. The Aria stem has a lateral shoulder and proximally coated with titanium plasma-spray.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
Start Date
September 15, 2021
Effective Date
September 15, 2021
Manufacturer
Country
Ireland
Address
Unit A IDA Business & Technology Park Garrycastle, Athlone, Co Westmeath, N37 DY26