aa53b447-58a7-4bdc-a8d6-9198d76cfecfUpdatePublished82020-12-092016-12-152020-09-18Not in Commercial Distribution00191375025375PrimaryGS1ENDOSKELETON® TCS Sterile Barrier System5366-1412-S5366-1412-S623316978TITAN SPINE, LLC1Interbody Fusion Device 6 Degree Medium 12mmtruefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(262)242-7801productinfo@titanspine.comK142589000K14294000038161Metallic 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.trueActiveODPIntervertebral fusion device with bone graft, cervicalOVEIntervertebral fusion device with integrated fixation, cervicalDepthWidthAngleDevice Size Text, specifywidth(MLxAP), 16 x 14, mmDevice Size Text, specifyLordotic Angle 6 DegHeighttruefalse