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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 Interlaminal
510(k) Number K090565
Device Name ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
Applicant
GLOBUS MEDICAL INC.
2560 GENERAL ARMISTEAD AVE.
AUDUBON,  PA  19403
Applicant Contact KELLY J BAKER
Correspondent
GLOBUS MEDICAL INC.
2560 GENERAL ARMISTEAD AVE.
AUDUBON,  PA  19403
Correspondent Contact KELLY J BAKER
Regulation Number888.3050
Classification Product Code
KWP  
Date Received03/02/2009
Decision Date 06/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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