FDA 510(k) Application Details - K151312

Device Classification Name	More FDA Info for this Device
510(K) Number	K151312
Device Name	VerteLP Interbody Fusion Device
Applicant	VGI, LLC 150 253rd Ave St. Petersburg, FL 33708 US Other 510(k) Applications for this Company
Contact	Tov Vestgaarten 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	05/18/2015
Decision Date	01/13/2016
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