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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with integrated fixation, lumbar
510(k) Number K112700
Device Name FRONTIER SADL INTERBODY FUSION DEVICE
Original Applicant
FRONTIER MEDICAL DEVICES, INC.
13540 guild avenue
apple valley,  MN  55124
Original Contact rich jansen
Regulation Number888.3080
Classification Product Code
OVD  
Date Received09/16/2011
Decision Date 11/01/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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