c021f488-de3f-4426-997f-1804910295dcUpdatePublished42022-04-272015-09-14In Commercial DistributionH981401392990SecondaryHIBCC10705034778891PrimaryGS1NA401.392.9940139299486711679Synthes GmbH12.4MM TI EMERGENCY SCREW WITH STARDRIVE(TM) RECESS 12MMfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)255-2500xx@xx.xxK03253400061325Bone-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.trueActiveNQWORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METALfalsetrueMoist Heat or Steam Sterilization