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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 bone graft, lumbar
510(k) Number K122097
Device Name PATRIOT SPACERS
Applicant
GLOBUS MEDICAL, INC.
2560 General Armistead Ave
VALLEY FORGE BUSINESS CENTER
AUDUBON,  PA  19403
Applicant Contact MERIAM YOUSSEF
Correspondent
GLOBUS MEDICAL, INC.
2560 General Armistead Ave
VALLEY FORGE BUSINESS CENTER
AUDUBON,  PA  19403
Correspondent Contact MERIAM YOUSSEF
Regulation Number888.3080
Classification Product Code
MAX  
Date Received07/16/2012
Decision Date 12/06/2012
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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