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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 K133567
Device Name UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
Applicant
GLOBUS MEDICAL INC.
2560 GENERAL ARMISTEAD AVE.
AUDUBON,  PA  19403
Applicant Contact CHRISTINA KICHULA
Correspondent
GLOBUS MEDICAL INC.
2560 GENERAL ARMISTEAD AVE.
AUDUBON,  PA  19403
Correspondent Contact CHRISTINA KICHULA
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received11/20/2013
Decision Date 02/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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