7f39a8b7-869b-4708-bb7d-3836e6386331UpdatePublished22018-03-292015-09-24In Commercial Distribution10705034250311PrimaryGS1EXPEDIUM175422425175422425482661753Medos International Sàrl1EXPEDIUM SPINE SYSTEM FIXED BOLT, STANDARD 4.35 x 25mmfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling 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.trueActiveKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALMNIORTHOSIS, SPINAL PEDICLE FIXATIONOSHPedicle screw spinal system, adolescent idiopathic scoliosisNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseMNHOrthosis, spondylolisthesis spinal fixationKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYfalsetrueMoist Heat or Steam Sterilization