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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 intervertebral body
510(k) Number K113329
Device Name K2M, PYRENEES CERVICAL PLATE SYSTEM
Original Applicant
K2M, INC.
751 miller dr.,se
leesburg,  VA  20175
Original Contact nancy giezen
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received11/14/2011
Decision Date 01/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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