FDA 510(k) Application Details - K122415

Device Classification Name	Pin, Fixation, Smooth   More FDA Info for this Device
510(K) Number	K122415
Device Name	Pin, Fixation, Smooth
Applicant	AREX USA LLC 1709 HILL ST. EDGEWATER, FL 32132 US Other 510(k) Applications for this Company
Contact	CHARLES HOKANSON Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2012
Decision Date	03/15/2013
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