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Actis DuoFix Hip Femoral Stem - Coated femoral stem prosthesis, modular - ARTG 346130

Access comprehensive regulatory information for Actis DuoFix Hip Femoral Stem - Coated femoral stem prosthesis, modular in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 346130 and sponsored by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes, manufactured by Depuy (Ireland) in Ireland. The device registration started on October 19, 2020.

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 III
ARTG 346130
Class III
Actis DuoFix Hip Femoral Stem - Coated femoral stem prosthesis, modular
ARTG ID: 346130
Good Name: Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Actis DuoFix Hip Femoral Stem - Coated femoral stem prosthesis, modular
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Intended Purpose

The Actis DuoFix Hip Femoral Stem is intended for use in total hip arthroplasty to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The Actis DuoFix Hip Femoral Stem is intended for use in hemi-hip arthroplasty where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
346130
Start Date
October 19, 2020
Effective Date
October 19, 2020
Manufacturer
Country
Ireland
Address
Loughbeg Ringaskiddy, COUNTY CORK