afac90f7-cea6-4772-8205-d855102964b9UpdatePublished42020-02-242015-09-14In Commercial DistributionH981088040410SecondaryHIBCC10705034754789PrimaryGS1VERTEBRAL SPACER-TR08.804.04108804041832637081SYNTHES (U.S.A.) LP1VERTEBRAL SPACER-TR 10MMX30MM 11MM HEIGHTfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)255-2500xx@xx.xxK01103700060762Polymeric 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.trueActiveMQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICEfalsetrueMoist Heat or Steam Sterilization