e9c60e73-92c5-4158-877a-73de1c8fb2d9UpdatePublished72023-06-212014-12-08In Commercial Distribution04546540561756PrimaryGS1XIA 3482307545482307545149183167Stryker Corporation1MONOAXIAL 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.trueActiveKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALOSHPedicle screw spinal system, adolescent idiopathic scoliosisMNHOrthosis, spondylolisthesis spinal fixationMNIORTHOSIS, SPINAL PEDICLE FIXATIONNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseDevice Size Text, specifyDiameter: 7.5 MillimeterLengthfalsetrueMoist Heat or Steam Sterilization