SkyWalker Total Knee System

Orthopedic Stereotaxic Instrument

MicroPort NaviBot International LLC

The following data is part of a premarket notification filed by Microport Navibot International Llc with the FDA for Skywalker Total Knee System.

Pre-market Notification Details

Device IDK213873
510k NumberK213873
Device Name:SkyWalker Total Knee System
ClassificationOrthopedic Stereotaxic Instrument
Applicant MicroPort NaviBot International LLC 300 Foxborough Blvd. Foxborough,  MA  02035
ContactMike Manor
CorrespondentJinmei Zhu
Shanghai MicroPort Medical (Group) Co., Ltd. No. 1601 ZhangDong Road, ZJ Hi-Tech Park Shanghai,  CN 201203
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-13
Decision Date2022-07-07

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