FDA 510(k) Application Details - K101400

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K101400
Device Name	Plate, Fixation, Bone
Applicant	CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. ZHONGSHAN NO. 2 ROAD (SOUTH) SUITE 5D, # 19, LANE 999 SHANGHAI 200030 CN Other 510(k) Applications for this Company
Contact	Diana Hong Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2010
Decision Date	11/09/2010
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