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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 K112724
Device Name DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
Original Applicant
MEDOS INTERNATIONAL SARL
325 paramount drive
raynham,  MA  02767
Original Contact eugene bang
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/19/2011
Decision Date 11/21/2011
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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