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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, facet screw spinal device
510(K) Number K120597
Device Name KOMPREDA
Applicant
CUSTOM SPINE, INC.
9 campus dr
parsippany,  NJ  07054
Contact david brumfield
Classification Product Code
MRW  
Date Received02/28/2012
Decision Date 05/03/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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