d6801e53-a998-4923-8358-56902d92c0d4UpdatePublished52019-09-092015-09-242018-11-30Not in Commercial Distribution10705034112145PrimaryGS1EXPEDIUM186212422186212422107105876DEPUY SPINE, LLC1EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 4.5 x 4.0 x 22.5mmfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)255-2500xx@xx.xxK073364000K11113600061325Bone-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.trueActiveMNHOrthosis, spondylolisthesis spinal fixationKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseOSHPedicle screw spinal system, adolescent idiopathic scoliosisMNIORTHOSIS, SPINAL PEDICLE FIXATIONKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALfalsetrueMoist Heat or Steam Sterilization