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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 K093242
Device Name PATRIOT TRANSCONTINENTAL LLIF SPACER
Applicant
GLOBUS MEDICAL, INC.
2560 GENERAL ARMISTEAD AVE.
VALLEY FORGE BUSINESS CENTER
AUDUBON,  PA  19403
Applicant Contact KELLY J BAKER
Correspondent
GLOBUS MEDICAL, INC.
2560 GENERAL ARMISTEAD AVE.
VALLEY FORGE BUSINESS CENTER
AUDUBON,  PA  19403
Correspondent Contact KELLY J BAKER
Regulation Number888.3080
Classification Product Code
MAX  
Date Received10/15/2009
Decision Date 12/23/2009
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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