ARTG 430931Custom-made orthopaedic surgical guide, non-sterile
ARTG ID: 430931 · MicroPort Orthopedics Pty Ltd · MicroPort Orthopedics Inc · Class IIa · Started December 15, 2023
Good Name: MicroPort Orthopedics Pty Ltd - Custom-made orthopaedic surgical guide, non-sterile
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 430931
- Start Date
- December 15, 2023
- Effective Date
- December 15, 2023
- Country
- United States of America
- Address
- 5677 Airline Road, Arlington, TN, 38002
Patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with MicroPort’s EVOLUTION® Total Knee Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for single use only.
Access comprehensive regulatory information for Custom-made orthopaedic surgical guide, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 430931 and sponsored by MicroPort Orthopedics Pty Ltd, manufactured by MicroPort Orthopedics Inc in United States of America. The device registration started on December 15, 2023.
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