FDA 510(k) Application Details - K132820

Device Classification Name	Pin, Fixation, Threaded   More FDA Info for this Device
510(K) Number	K132820
Device Name	Pin, Fixation, Threaded
Applicant	VILEX, INC. 7214 LAKE FOREST GLEN LAKEWOOD RANCH, FL 34202 US Other 510(k) Applications for this Company
Contact	ABRAHAM LAVI Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	JDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2013
Decision Date	07/23/2014
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