69e683f8-4fd7-4bb6-90dc-59e3c6e1d543UpdatePublished32018-07-062016-04-15In Commercial Distribution00190361014782PrimaryGS1PedFuse®01-80184-25002003243SPINEFRONTIER, INC.1Screw Assy REset Solid 5.0X25mm Gen 3truefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(866)914-7717customerservice@spinefrontier.comK12316400061325Bone-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 FIXATIONMNHOrthosis, spondylolisthesis spinal fixationOuter DiameterLengthfalsetrueMoist Heat or Steam Sterilization