8ff5e9e8-bf24-46c9-b949-fcf7cbd4f71fUpdatePublished42020-02-242016-04-15In Commercial Distribution00190361021599PrimaryGS1A-CIFT® SoloFuse®01-32017-08002003243SPINEFRONTIER, INC.1A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic 13LX17W, 8mmtruefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(866)914-7717customerservice@spinefrontier.comK13188000060762Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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.trueActiveOVEIntervertebral fusion device with integrated fixation, cervicalLengthHeightWidthfalsetrueMoist Heat or Steam Sterilization