FDA 510(k) Application Details - K113285

Device Classification Name	More FDA Info for this Device
510(K) Number	K113285
Device Name	LDR SPINE USA AVENUE L INTERBODY FUSION
Applicant	LDR SPINE USA INC. 13785 RESEARCH BOULEVARD SUITE 200 AUSTIN, TX 78750 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	11/07/2011
Decision Date	07/26/2012
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