edc7738b-cf85-4ceb-b843-c4787e169866UpdatePublished42021-06-032016-02-23In Commercial DistributionM697C08000320Direct MarkingHIBCCM697C08000321PrimaryHIBCCIrix-A Lumbar Integrated Fusion SystemC080-0032081224143Xtant Medical Holdings, Inc.117 MM SPECIALTY 42X30X8 DEG IRIX A MODULAR TRIAL HEADfalsetruefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(937)847-8400orders@x-spine.com60847Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Fixation screws and disposable devices associated with implantation may be included with the device.falseObsoleteHWTTEMPLATEfalsetrueMoist Heat or Steam Sterilization