Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K213873
Device Name SkyWalker Total Knee System
Applicant
Microport Navibot International, LLC
300 Foxborough Blvd.
Foxborough,  MA  02035
Applicant Contact Mike Manor
Correspondent
Shanghai MicroPort Medical (Group) Co., Ltd.
1601 Zhangdong Rd., Zj Hi-Tech Park
Shanghai,  CN 201203
Correspondent Contact Jinmei Zhu
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/13/2021
Decision Date 07/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-