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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fastener, fixation, nondegradable, soft tissue
510(k) Number K120841
Models KFX-GTO-150, KFX-MST-150, KFX-MST-160
Device Name APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR
Original Applicant
KFX MEDICAL
5845 avenida encinas, suite 128
carlsbad,  CA  92008
Original Contact gayle hirota
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/20/2012
Decision Date 06/07/2012
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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