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Attune Medial Stabilised Fixed Bearing Insert - Prosthesis, knee, internal, insert component - ARTG 482545

Access comprehensive regulatory information for Attune Medial Stabilised Fixed Bearing 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 482545 and sponsored by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes, manufactured by DePuy Ireland UC in Ireland. The device registration started on March 14, 2025.

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 III
ARTG 482545
Class III
Attune Medial Stabilised Fixed Bearing Insert - Prosthesis, knee, internal, insert component
ARTG ID: 482545
Good Name: Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Attune Medial Stabilised Fixed Bearing Insert - Prosthesis, knee, internal, insert component
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Intended Purpose

The ATTUNE Medial Stabilised Fixed Bearing Insert is a component of the ATTUNE Total Knee System which is intended to replace articulating elements of a damaged knee joint where there is evidence of sufficient sound bone to seat and support the components.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482545
Start Date
March 14, 2025
Effective Date
March 14, 2025
Manufacturer
Country
Ireland
Address
Loughbeg Ringaskiddy, Co Cork