f50c4538-1074-481c-8ba0-d88af78a6087UpdatePublished52024-11-182015-10-30In Commercial DistributionM697X08060401PrimaryHIBCCIrix-A Lumbar Integrated Fusion SystemX080-6040081224143Xtant Medical Holdings, Inc.16.0 X 40mm, IRIX-A, RESCUE SCREWfalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(888)886-9354cs@xtantmedical.com46651Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.trueActiveOVDIntervertebral fusion device with integrated fixation, lumbarLengthOuter DiameterfalsetrueMoist Heat or Steam Sterilization