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 K171267
Device Name NavLock Trackers
Applicant
Medtronic Navigation
826 Coal Creek Circle
Louisville,  CO  80027
Applicant Contact Nicole Zimmerman
Correspondent
Medtronic Navigation
826 Coal Creek Circle
Louisville,  CO  80027
Correspondent Contact Nicole Zimmerman
Regulation Number882.4560
Classification Product Code
OLO  
Date Received05/01/2017
Decision Date 07/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-