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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
Device Name APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR
Applicant
KFX MEDICAL
5845 Avenida Encinas, Suite 128
CARLSBAD,  CA  92008
Applicant Contact GAYLE HIROTA
Correspondent
KFX MEDICAL
5845 Avenida Encinas, Suite 128
CARLSBAD,  CA  92008
Correspondent Contact GAYLE HIROTA
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/20/2012
Decision Date 06/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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