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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 K152239
Device Name Zero-P Natural Plate System
Applicant
Synthes (Usa), LLC
1051 Synthes Ave.
Monument,  CO  80132
Applicant Contact Beth Becotte
Correspondent
DePuy Synthes
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Laura Bleyendaal
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/10/2015
Decision Date 12/02/2015
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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