7ecaa2d1-e3d7-4189-83dc-65666117145bUpdatePublished22018-03-292015-09-14In Commercial Distribution07613327122114PrimaryGS1OASYS4855443648554436149183167Stryker Corporation1BONE 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 INTERLAMINALMRWSYSTEM, FACET SCREW SPINAL DEVICELengthDevice Size Text, specifyDiameter: 4.0 MillimeterfalsetrueMoist Heat or Steam Sterilization