Pure Global

EVOLUTION® Revision CCK Tibial Insert - Prosthesis, knee, internal, insert component

Access comprehensive regulatory information for EVOLUTION® Revision CCK 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 sponsored by MicroPort Orthopedics Pty Ltd, manufactured by MicroPort Orthopedics Inc in United States of America. The device registration started on May 16, 2019.

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
Class III
EVOLUTION® Revision CCK Tibial Insert - Prosthesis, knee, internal, insert component
Australia TGA ARTG Registered Device
Good Name: MicroPort Orthopedics Pty Ltd - EVOLUTION® Revision CCK Tibial Insert - Prosthesis, knee, internal, insert component
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Intended Purpose

A total knee system component used to replace the bearing surface for the distal femoral component. Indicated for use in knee arthroplasty in skeletally mature patients with the following condition: 1) revision procedures where other treatments or devices have failed.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 16, 2019
Effective Date
May 16, 2019
Manufacturer
Country
United States of America
Address
5677 Airline Road, Arlington, TN, 38002