ARTG 471126PEEK Skull Repairing System - Cranofacial fixation plate, non-biodegradable
ARTG ID: 471126 · Innovative Medcare Technology Pty Ltd · Kontour (Xi'an) Medical Technology Co. Ltd. · Class IIb · Started November 29, 2024
Good Name: Innovative Medcare Technology Pty Ltd - PEEK Skull Repairing System - Cranofacial fixation plate, non-biodegradable
- Risk Class
- Class IIb
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 471126
- Start Date
- November 29, 2024
- Effective Date
- November 29, 2024
- Country
- China
- Address
- No 1451 1st Biyuan Road High-Tech District, Xi'an, Shaanxi, 710065
The PEEK Skull Repairing Systems are applicable to the surgical treatment for repairing and reconstruction of the skull defect. It consists of PEEK link plates (two-hole, four-hole and snow link plate). Tools for Implantation may be included. These patient matched medical devices are for long term use and are not in direct contact with the CNS or CCS.
Access comprehensive regulatory information for PEEK Skull Repairing System - Cranofacial fixation plate, non-biodegradable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 471126 and sponsored by Innovative Medcare Technology Pty Ltd, manufactured by Kontour (Xi'an) Medical Technology Co. Ltd. in China. The device registration started on November 29, 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.