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Prosthesis, internal, joint, knee, <specify> - ARTG 447218

Access comprehensive regulatory information for Prosthesis, internal, joint, knee, <specify> in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 447218 and sponsored by Signature Orthopaedics Pty Ltd, manufactured by Signature Orthopaedics Pty Ltd in Australia. The device registration started on April 30, 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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TGA ARTG Official Data
Class I
ARTG 447218
Class I
Prosthesis, internal, joint, knee, <specify>
ARTG ID: 447218
Good Name: Signature Orthopaedics Pty Ltd - Prosthesis, internal, joint, knee, <specify>
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Intended Purpose

The cemented knee system consists of a femoral component, meniscal inserts, a locking bar for the meniscal insert, a patella and a tibial base plate with a tibial post and bolt. The device is designed for a total knee replacement of deficient and/or damaged knee articulating joints, and lost or damaged bone structures supporting the bearing surface in skeletally mature patients.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
ARTG ID
447218
Start Date
April 30, 2024
Effective Date
April 30, 2024
Manufacturer
Country
Australia
Address
7 Sirius Road, LANE COVE WEST, NSW, 2066