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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K142838
Device Name Synapse Occipital-Cervical-Thoracic (OCT) System
Applicant
Synthes USA Products, LLC
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact KATE LAROSE
Correspondent
Synthes USA Products, LLC
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact KATE LAROSE
Regulation Number888.3075
Classification Product Code
NKG  
Date Received09/30/2014
Decision Date 01/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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