59a7b282-1427-48e6-996f-1b24b1883e84UpdatePublished52022-04-272016-06-30In Commercial DistributionH98108815336S0SecondaryHIBCC10705034814759PrimaryGS1SYNFIX Evolution08.815.336S08815336S486711679Synthes GmbH1SYNFIX® EVOLUTION SPACER LG DEEP/19MM HEIGHT/6°-STERtruefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)255-2500xx@xx.xxK15067300060762Polymeric 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.trueActiveOVDIntervertebral fusion device with integrated fixation, lumbartruefalse