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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K121808
Device Name CASIAN, 3.5/4.5 CONNECTORS
Original Applicant
751 miller dr.,se
leesburg,  VA  20175
Original Contact nancy giezen
Regulation Number888.3050
Classification Product Code
Subsequent Product Code
Date Received06/20/2012
Decision Date 07/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No