fd9acdad-b665-4af8-bc3f-96cfdd58f682UpdatePublished82020-12-092016-12-152020-09-18Not in Commercial Distribution00191375020097PrimaryGS1ENDOSKELETON® TO Sterile Barrier System3110-2210-S3110-2210-S623316978TITAN SPINE, LLC1Interbody Fusion Device 0 Degree Convex PLIF 10mmtruefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(262)242-7801productinfo@titanspine.comK102067000K14258900038161Metallic 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, lumbarWidthDepthDevice Size Text, specifywidth(MLxAP), 22 x 9, mmHeightDevice Size Text, specify0 Deg Convextruefalse