FDA 510(k) Application Details - K152568

Device Classification Name	More FDA Info for this Device
510(K) Number	K152568
Device Name	C-VBR
Applicant	CARDINAL SPINE, LLC 12307 OLD LAGRANGE ROAD, SUITE 105 LOUISVILLE, KY 40245 US Other 510(k) Applications for this Company
Contact	NATASHA LONNON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2015
Decision Date	02/11/2016
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