3fe8968b-1831-4487-8508-913efeeb4d57UpdatePublished62023-06-212014-12-08In Commercial Distribution04546540149084PrimaryGS1XIA II0382086003820860149183167Stryker 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.trueActiveMNIORTHOSIS, SPINAL PEDICLE FIXATIONKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseMNHOrthosis, spondylolisthesis spinal fixationKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALLengthDevice Size Text, specifyDiameter: 8.5 MillimeterfalsetrueMoist Heat or Steam Sterilization