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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spine, plate, laminoplasty, metal
510(k) Number K121732
Device Name CANOPY LAMINOPLASTY FIXATION SYSTEM
Original Applicant
GLOBUS MEDICAL INC.
2560 general armistead ave.
audubon,  PA  19403
Original Contact sarah marie fitzgerald
Regulation Number888.3050
Classification Product Code
NQW  
Date Received06/13/2012
Decision Date 10/31/2012
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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