FDA 510(k) Application Details - K142030

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K142030
Device Name	Spinal Vertebral Body Replacement Device
Applicant	CARDINAL SPINE, LLC 12264 EL CAMINO REAL, SUITE 400 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	KEVIN A. THOMAS Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	MQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2014
Decision Date	01/23/2015
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