FDA 510(k) Application Details - K101175

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K101175
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	KFX MEDICAL 5845 AVENIDA ENCINAS,SUITE 128 CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	GAYLE HIROTA Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2010
Decision Date	05/20/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review