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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spinal pedicle fixation
510(k) Number K120656
Device Name EVEREST SPINAL SYSTEM
Original Applicant
K2M, INC.
751 miller drive se
leesburg,  VA  20175
Original Contact nancy giezen
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received03/05/2012
Decision Date 04/04/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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