FDA 510(k) Application Details - K141937

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K141937
Device Name	Screw, Fixation, Bone
Applicant	VILEX IN TENNESSEE, INC. 8374 MARKET STREET, #167 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	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2014
Decision Date	09/10/2014
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