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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 K130825
Device Name AZURE ANTERIOR CERVICAL PLATE SYSTEM
Applicant
ORTHOFIX, INC.
3451 PLANO PARKWAY
LEWISVILLE,  TX  75056
Applicant Contact ALLY BADUEL
Correspondent
ORTHOFIX, INC.
3451 PLANO PARKWAY
LEWISVILLE,  TX  75056
Correspondent Contact ALLY BADUEL
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/26/2013
Decision Date 05/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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