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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, lumbar
510(K) Number K120101
Device Name INDEPENDENCE SPACER
Applicant
GLOBUS MEDICAL INC.
2560 general armistead ave.
audubon,  PA  19403
Contact meriam youssef
Regulation Number888.3080
Classification Product Code
OVD  
Date Received01/12/2012
Decision Date 03/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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