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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 K133698
Device Name SYNAPSE SYSTEM
Applicant
Synthes USA Products, LLC
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact LAURA BLEYENDAAL
Correspondent
Synthes USA Products, LLC
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact LAURA BLEYENDAAL
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received12/03/2013
Decision Date 01/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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