FDA 510(k) Application Details - K162133

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K162133
Device Name	Spinal Vertebral Body Replacement Device
Applicant	LDR SPINE USA, INC. 13785 RESEARCH BLVD SUITE 200 AUSTIN, TX 78750 US Other 510(k) Applications for this Company
Contact	JAMIE WILSON 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	08/01/2016
Decision Date	05/16/2017
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