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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spinal pedicle fixation, for degenerative disc disease
510(K) Number K121922
Device Name BEACON STABILIZATION SYSTEM
Applicant
GLOBUS MEDICAL INC.
2560 general armistead ave.
audubon,  PA  19403
Contact meriam youssef
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received07/02/2012
Decision Date 07/26/2012
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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