FDA 510(k) Application Details - K131609

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K131609
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD NO. 218, HOUXIANG ROAD HAICANG DISTRICT XIAMEN, FUJIAN 361022 CN Other 510(k) Applications for this Company
Contact	DA ZENG Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2013
Decision Date	05/21/2014
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