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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 K170011
Device Name StealthStation S8 Spine Software v1.0.0
Applicant
Medtronic Navigation
826 Coal Creek Circle
Louisville,  CO  80027
Applicant Contact JOHN CONNOR
Correspondent
Medtronic Navigation
826 Coal Creek Circle
Louisville,  CO  80027
Correspondent Contact JOHN CONNOR
Regulation Number882.4560
Classification Product Code
OLO  
Date Received01/03/2017
Decision Date 05/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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