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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with integrated fixation, cervical
510(k) Number K131449
Device Name COALITION SPACER
Applicant
GLOBUS MEDICAL, INC.
2560 General Armistead Ave
VALLEY FORGE BUSINESS CENTER
AUDUBON,  PA  19403
Applicant Contact CHRISTINA KICHULA
Correspondent
GLOBUS MEDICAL, INC.
2560 General Armistead Ave
VALLEY FORGE BUSINESS CENTER
AUDUBON,  PA  19403
Correspondent Contact CHRISTINA KICHULA
Regulation Number888.3080
Classification Product Code
OVE  
Date Received05/20/2013
Decision Date 07/30/2013
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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