a5ea4180-f41e-4b16-8d94-bb4c4ab677d1UpdatePublished22018-03-292015-09-24In Commercial Distribution10705034442129PrimaryGS1EXPEDIUM VERSE199721735199721735482661753Medos International Sàrl1EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 7.0 x 35mmfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling 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.trueActiveOSHPedicle screw spinal system, adolescent idiopathic scoliosisKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseMNIORTHOSIS, SPINAL PEDICLE FIXATIONMNHOrthosis, spondylolisthesis spinal fixationKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYfalsetrueMoist Heat or Steam Sterilization