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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K221087
Device Name Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
Applicant
Medtronic Navigation, Inc.
826 Coal Creek Cir.
Louisville,  CO  80027
Applicant Contact Silver Wirth
Correspondent
Medtronic Navigation, Inc.
826 Coal Creek Cir.
Louisville,  CO  80027
Correspondent Contact Silver Wirth
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/13/2022
Decision Date 06/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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