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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 K162638
Device Name CETRA Anterior Cervical Plate System
Applicant
Orthofix, Inc.
3451 Plano Pkwy.
Lewisville,  TX  75056
Applicant Contact Jacki Koch
Correspondent
Orthofix, Inc.
3451 Plano Pkwy.
Lewisville,  TX  75056
Correspondent Contact Jacki Koch
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/22/2016
Decision Date 12/16/2016
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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