FDA 510(k) Application Details - K142589

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K142589
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	TITAN SPINE, LLC 6140 WEST EXECUTIVE DRIVE, SUITE A MEQUON, WI 53092 US Other 510(k) Applications for this Company
Contact	Jane Rodd Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	MAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2014
Decision Date	10/17/2014
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