FDA 510(k) Application Details - K162849

Device Classification Name	More FDA Info for this Device
510(K) Number	K162849
Device Name	Huvex Interspinous Fixation System
Applicant	DIO MEDICAL CO., LTD. 101-105 MEGACENTER, SK TECHNOPARK 190-1 SANGDAWON-DONG JUNGWON-GU SUNGNAM-SI 462-850 KR Other 510(k) Applications for this Company
Contact	LEE SUNG-HEE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/11/2016
Decision Date	02/16/2017
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