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SkyWalker Total Knee System - Robot, surgical, navigation unit

Australia TGA ARTG Registered Device · MicroPort Orthopedics Pty Ltd · MicroPort NaviBot (Suzhou) Co Ltd · Class IIa · Started July 14, 2023

Good Name: MicroPort Orthopedics Pty Ltd - SkyWalker Total Knee System - Robot, surgical, navigation unit

Device classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration information
Start Date
July 14, 2023
Effective Date
July 14, 2023
Sponsor
Manufacturer
Country
China
Address
No3 Workshop No151 Fengli Street, Suzhou Industrial Park, Suzhou Jiangsu, 215024
Intended purpose

To assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures in Total Knee Arthroplasty (TKA) procedures

About this record

Access comprehensive regulatory information for SkyWalker Total Knee System - Robot, surgical, navigation unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by MicroPort Orthopedics Pty Ltd, manufactured by MicroPort NaviBot (Suzhou) Co Ltd in China. The device registration started on July 14, 2023.

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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