Pure Global

GENUS PANTHEON CCK Fixed tibial insert - Prosthesis, knee, internal, insert component - ARTG 462831

Access comprehensive regulatory information for GENUS PANTHEON CCK Fixed tibial insert - Prosthesis, knee, internal, insert component in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 462831 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class III
ARTG 462831
Class III
GENUS PANTHEON CCK Fixed tibial insert - Prosthesis, knee, internal, insert component
ARTG ID: 462831
Good Name: Adler Ortho Australia Pty Ltd - GENUS PANTHEON CCK Fixed tibial insert - Prosthesis, knee, internal, insert component
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

A fixed knee insert 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.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
462831
Start Date
September 25, 2024
Effective Date
September 25, 2024
Manufacturer
Country
Italy
Address
9 Via dell'innovazione, Cormano, MI, 20032