b59564b7-9269-4a5e-9fa7-40a659530547UpdatePublished62023-06-212014-12-08In Commercial Distribution07613154513246PrimaryGS1RADIUS486610670486610670149183167Stryker Corporation1STANDARD 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 FIXATIONKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYMNHOrthosis, spondylolisthesis spinal fixationNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseDevice Size Text, specifyDiameter: 6.75 MillimeterLengthfalsetrueMoist Heat or Steam Sterilization