18b31674-a775-4952-80a5-b71a3f6e320dUpdatePublished62023-06-212014-12-08In Commercial Distribution07613154122332PrimaryGS1XIA 4 54814454548144545149183167Stryker 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.trueActiveMNIORTHOSIS, SPINAL PEDICLE FIXATIONNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseOSHPedicle screw spinal system, adolescent idiopathic scoliosisMNHOrthosis, spondylolisthesis spinal fixationKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALDevice Size Text, specifyDiameter: 4.5 MillimeterLengthfalsetrueMoist Heat or Steam Sterilization