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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 K151938
Device Name S4 Cervical Spinal and Occiput Systems
Applicant
Aesculap Implant Systems, LLC
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact LISA BOYLE
Correspondent
Aesculap Implant Systems, LLC
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact LISA M. BOYLE
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received07/14/2015
Decision Date 10/21/2015
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
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