FDA 510(k) Application Details - K151934

Device Classification Name	More FDA Info for this Device
510(K) Number	K151934
Device Name	ROI-C Titanium-Coated Implant System
Applicant	LDR SPINE USA 13785 RESEARCH BOULEVARD, SUITE 200 AUSTIN, TX 78750 US Other 510(k) Applications for this Company
Contact	JAMES WILSON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2015
Decision Date	12/07/2015
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