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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K150552
Device Name ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
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 Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received03/04/2015
Decision Date 06/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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