7f4b86e4-e192-4965-99c4-7b8e260d8edcUpdatePublished22018-03-292015-09-24In Commercial Distribution10705034067933PrimaryGS1EXPEDIUM179712760179712760482661753Medos International Sàrl1EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 x 7 x 60mmfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)255-2500xx@xx.xx61325Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.trueActiveKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseMNIORTHOSIS, SPINAL PEDICLE FIXATIONMNHOrthosis, spondylolisthesis spinal fixationOSHPedicle screw spinal system, adolescent idiopathic scoliosisKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALfalsetrueMoist Heat or Steam Sterilization