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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 K113654
Device Name CASPIAN
Original Applicant
K2M, INC.
751 miller dr.,se
leesburg,  VA  20175
Original Contact nancy giezen
Regulation Number888.3050
Classification Product Code
KWP  
Date Received12/13/2011
Decision Date 01/12/2012
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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