Australia flagARTG 462826

GENUS PANTHEON Fixed Ti6Al4V tibial tray cemented - Uncoated knee tibia prosthesis, metallic

ARTG ID: 462826 · Adler Ortho Australia Pty Ltd · Adler Ortho SpA · Class III · Started September 25, 2024

Good Name: Adler Ortho Australia Pty Ltd - GENUS PANTHEON Fixed Ti6Al4V tibial tray cemented - Uncoated knee tibia prosthesis, metallic

Device classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
462826
Start Date
September 25, 2024
Effective Date
September 25, 2024
Sponsor
Manufacturer
Country
Italy
Address
9 Via dell'innovazione, Cormano, MI, 20032
Intended purpose

A cemented fixed tibial component of the GENUS PANTHEON knee. The GENUS PANTHEON knee is intended for treatment of patients who are candidates for total knee arthroplasty per the following indications for use: - Complex primary surgeries, - Moderate bone loss, - Revisions, where other devices or treatments have failed.

About this record

Access comprehensive regulatory information for GENUS PANTHEON Fixed Ti6Al4V tibial tray cemented - Uncoated knee tibia prosthesis, metallic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 462826 and sponsored by Adler Ortho Australia Pty Ltd, manufactured by Adler Ortho SpA in Italy. The device registration started on September 25, 2024.

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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