5982289f-a860-4c13-b5c8-2efa308a3f4aUpdatePublished62024-09-112015-08-19In Commercial Distribution00885074451237PrimaryGS1VERTEX® Reconstruction System6950315830350380MEDTRONIC SOFAMOR DANEK, INC.1SET SCREW 6950315 M6 SET SCREWfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)633-8766Corporate.UDI@medtronic.comK042498000K05218000046651Spinal 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.trueActiveKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALfalsetrueMoist Heat or Steam Sterilization