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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 K121658
Device Name ORTHOFIX ACP (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 Received06/05/2012
Decision Date 07/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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