1fbad95e-85a2-49ef-8b89-43637fcba734UpdatePublished72023-06-212014-12-08In Commercial Distribution04546540598608PrimaryGS1XIA 3482318550482318550149183167Stryker Corporation1POLYAXIAL SCREWfalsefalsefalsefalsefalsetruetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse61325Bone-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 diseaseMNIORTHOSIS, SPINAL PEDICLE FIXATIONKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALLengthDevice Size Text, specifyDiameter: 8.5 MillimeterfalsetrueMoist Heat or Steam Sterilization