FDA 510(k) Application Details - K132428

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K132428
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT 503 ROOM, 8 BLDG, 600 LIU ZHOU ROAD SHANGHAI 200233 CN Other 510(k) Applications for this Company
Contact	GONG BO 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	08/05/2013
Decision Date	12/20/2013
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