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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal interlaminal
510(K) Number K121191
Device Name VERTEX RCCONSTRUCTION SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 pyramid place
memphis,  TN  38132
Contact claire evans
Regulation Number888.3050
Classification Product Code
KWP  
Date Received04/19/2012
Decision Date 06/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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