FDA 510(k) Application Details - K141106

Device Classification Name	More FDA Info for this Device
510(K) Number	K141106
Device Name	FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM
Applicant	FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES 153A CAHABA VALLEY PARKWAY PELHAM, AL 35124 US Other 510(k) Applications for this Company
Contact	KEVIN ETHERIDGE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/2014
Decision Date	10/10/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review