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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 K201189
Device Name Stealthstation S8 Spine Software v1.3.0
Applicant
Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville,  CO  80027
Applicant Contact Jason Woehrle
Correspondent
Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville,  CO  80027
Correspondent Contact Jason Woehrle
Regulation Number882.4560
Classification Product Code
OLO  
Date Received05/01/2020
Decision Date 05/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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