16f562db-884b-48d7-9f3c-9d8465cd38ddUpdatePublished72026-01-192015-09-24In Commercial Distribution08800033366249PrimaryGS14CIS VANE SPINE SYSTEM4022-70454022-7045687844241ALPHA AI CO.,LTD.1Mono Reduction Pedicle Screw, 7.0x45mmfalsefalsefalsefalsefalsetruetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK10181800046651Spinal 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.trueActiveMNIOrthosis, Spinal Pedicle FixationMNHOrthosis, Spondylolisthesis Spinal FixationfalsetrueMoist Heat or Steam Sterilization