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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 K140454
Device Name NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
Applicant
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Applicant Contact REGINA HOLMES
Correspondent
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Correspondent Contact REGINA HOLMES
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
HBE  
Date Received02/24/2014
Decision Date 05/22/2014
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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