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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 K083609
Device Name KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE
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 Received12/08/2008
Decision Date 03/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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