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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 K124004
Device Name NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
Applicant
MEDTRONIC NAVIGATION, INC.
826 Coal Creek Circle
Louisville,  CO  80027
Applicant Contact MICHAEL BLASCO
Correspondent
MEDTRONIC NAVIGATION, INC.
826 Coal Creek Circle
Louisville,  CO  80027
Correspondent Contact MICHAEL BLASCO
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/26/2012
Decision Date 03/22/2013
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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