91a919f2-57ef-45bb-a73a-a35bb3c70873UpdatePublished92020-12-092016-12-152020-09-18Not in Commercial Distribution00191375018193PrimaryGS1ENDOSKELETON® TL nanoLOCK® Surface Technology7112-2413-N7112-2413-N623316978TITAN SPINE, LLC1Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 13 mmtruefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(262)242-7801productinfo@titanspine.comK140055000K14195300038161Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.trueActiveMAXIntervertebral fusion device with bone graft, lumbarDevice Size Text, specifywidth(MLxAP), 55 x 26, mmAngleWidthLengthDevice Size Text, specifyLordotic Angle 12 DegHeighttruefalse