f549126f-054a-435c-93d8-da82f95468b4UpdatePublished32022-04-272015-09-14In Commercial DistributionH9814980220SecondaryHIBCC10705034788630PrimaryGS1NA498.022498022486711679Synthes GmbH1TI 12-POINT NUT-10.5MMfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling 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.trueActiveMNHOrthosis, spondylolisthesis spinal fixationKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALMNIORTHOSIS, SPINAL PEDICLE FIXATIONKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYNKBOrthosis, spinal pedicle fixation, for degenerative disc diseasefalsetrueMoist Heat or Steam Sterilization