FDA 510(k) Application Details - K110327

Device Classification Name	More FDA Info for this Device
510(K) Number	K110327
Device Name	LDR SPINE ROI-A INTERBODY FUSION SYSTEM
Applicant	LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 AUSTIN, TX 78759 US Other 510(k) Applications for this Company
Contact	MARITZA ELIAS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2011
Decision Date	09/30/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review