FDA 510(k) Application Details - K142290

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K142290
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD SHA ZHOU EAST ROAD ZHANGJIAGANG CITY 215625 CN Other 510(k) Applications for this Company
Contact	Jin Hua Huang Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2014
Decision Date	11/24/2014
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