FDA 510(k) Application Details - K143631

Device Classification Name	More FDA Info for this Device
510(K) Number	K143631
Device Name	Benefix Interspinous Fixation System
Applicant	U & I Corporation 20, Sandan-ro 76beon-gil/(Rd) Uijeongbu-si 480-859 KR Other 510(k) Applications for this Company
Contact	Young-Geun Kim 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	12/22/2014
Decision Date	09/03/2015
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