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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 K201327
Device Name NavLock Trackers
Applicant
Medtronic Navigation
826 Coal Creek Cir.
Louisville,  CO  80027
Applicant Contact Taylor Gold West
Correspondent
Medtronic Navigation
826 Coal Creek Cir.
Louisville,  CO  80027
Correspondent Contact Taylor Gold West
Regulation Number882.4560
Classification Product Code
OLO  
Date Received05/19/2020
Decision Date 06/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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