5e574a28-9945-4735-bb5e-95777bd62a6cUpdatePublished42022-04-262015-09-14In Commercial DistributionH981046162250SecondaryHIBCC10705034741291PrimaryGS1NA04.616.22504616225486711679Synthes GmbH15.5MM TI ROD 125MMfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)255-2500xx@xx.xxK09292900061325Bone-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.trueActiveMNIORTHOSIS, SPINAL PEDICLE FIXATIONMNHOrthosis, spondylolisthesis spinal fixationNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALfalsetrueMoist Heat or Steam Sterilization