FDA 510(k) Application Details - K152324

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K152324
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	BEIJING WEIGAO YAHUA ARTIFICIAL JOINT DEVELOPMENT CO. LTD. NO.7, NIUHUI STREET, NIULANSHAN TOWN, SHUNYI DISTRICT BEIJING 101301 CN Other 510(k) Applications for this Company
Contact	XINJIAN LV Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2015
Decision Date	02/01/2016
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