265ae246-0134-4009-918b-b99e99e605b2UpdatePublished32022-04-262015-09-14In Commercial DistributionH981046029650SecondaryHIBCC10705034735054PrimaryGS1USS04.602.96504602965486711679Synthes GmbH19.0MM TI DUAL CORE USS SCREW 65MM THRD LENGTH F/6.0MM RODSfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling 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 FIXATIONKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseMNHOrthosis, spondylolisthesis spinal fixationfalsetrueMoist Heat or Steam Sterilization