a710582b-22e2-4ca0-931a-c295898887d1UpdatePublished52024-09-112018-02-03In Commercial Distribution00643169784635PrimaryGS1CD HORIZON® SOLERA® VOYAGER™ Spinal System55850019515830350380MEDTRONIC SOFAMOR DANEK, INC.1SCREW 55850019515 5.5 VOYAGER MAS 9.5X15falsefalsefalsefalsetruetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)633-8766Corporate.UDI@medtronic.comK17067900046651Spinal 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.trueActiveOLOOrthopedic stereotaxic instrumentKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALNKBThoracolumbosacral pedicle screw systemHWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENTKWQAppliance, fixation, spinal intervertebral bodyOuter DiameterfalsetrueMoist Heat or Steam Sterilization