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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
Original Applicant
9 campus dr
parsippany,  NJ  07054
Original Contact david brumfield
Classification Product Code
Date Received02/28/2012
Decision Date 05/03/2013
Decision substantially equivalent (SESE)
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No