Pure Global

SkyWalker Total Knee System - Robot, surgical, navigation unit - ARTG 413490

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 registered under ARTG number 413490 and 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
ARTG 413490
Class IIa
SkyWalker Total Knee System - Robot, surgical, navigation unit
ARTG ID: 413490
Good Name: MicroPort Orthopedics Pty Ltd - SkyWalker Total Knee System - Robot, surgical, navigation unit
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
413490
Start Date
July 14, 2023
Effective Date
July 14, 2023
Manufacturer
Country
China
Address
No3 Workshop No151 Fengli Street, Suzhou Industrial Park, Suzhou Jiangsu, 215024