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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spinal vertebral body replacement device
510(k) Number K121107
Device Name FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
Original Applicant
GLOBUS MEDICAL, INC.
2560 general armistead ave.
audubon,  PA  19403
Original Contact sarah m fitzgerald
Regulation Number888.3060
Classification Product Code
MQP  
Date Received04/12/2012
Decision Date 07/03/2012
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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