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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthopedic stereotaxic instrument
510(k) Number K182104
Device Name NavLock Trackers, Robotic Reference Frame
Applicant
Medtronic Navigation
826 Coal Creek Circle
Louisville,  CO  80027
Applicant Contact Jainam Shah
Correspondent
Medtronic Navigation
826 Coal Creek Circle
Louisville,  CO  80027
Correspondent Contact Jainam Shah
Regulation Number882.4560
Classification Product Code
OLO  
Date Received08/03/2018
Decision Date 11/02/2018
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
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