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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 K143028
Device Name Azure Anterior Cervical Plate System
Applicant
Orthofix, Inc.
3451 Plano Pkwy.
Lweisville,  TX  75056
Applicant Contact Natalia Volosen
Correspondent
Orthofix, Inc.
3451 Plano Pkwy.
Lweisville,  TX  75056
Correspondent Contact Natalia Volosen
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/21/2014
Decision Date 05/29/2015
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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