0f45bc5b-9527-49be-82ec-a320c7a54444UpdatePublished52019-09-092015-09-242018-11-30Not in Commercial Distribution10705034115511PrimaryGS1EXPEDIUM186254350186254350107105876DEPUY SPINE, LLC1EXPEDIUM SPINE SYSTEM CLOSED HOOK - NARROW 4.5 x 5.5mmfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling 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 fixationNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseOSHPedicle screw spinal system, adolescent idiopathic scoliosisMNIORTHOSIS, SPINAL PEDICLE FIXATIONKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYfalsetrueMoist Heat or Steam Sterilization