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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 K061294
Device Name KFX KNOTLESS FIXATION SYSTEM
Applicant
Kfx Medical
5145 Avenida Encinas, Suite C
Carlsbad,  CA  92008
Applicant Contact MALCOLM HEAVEN
Correspondent
Kfx Medical
5145 Avenida Encinas, Suite C
Carlsbad,  CA  92008
Correspondent Contact MALCOLM HEAVEN
Regulation Number888.3040
Classification Product Code
MBI  
Date Received05/09/2006
Decision Date 07/19/2006
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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