fdb65bbc-27d5-47d5-81fa-9ab6968481cdUpdatePublished32018-07-062016-04-15In Commercial Distribution00190361016144PrimaryGS1PedFuse®IM80023-03002003243SPINEFRONTIER, INC.1Pedicle Screw Assy, 8.0mm x 40mmtruefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(866)914-7717customerservice@spinefrontier.comK09242000061325Bone-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 fixationLengthOuter DiameterfalsetrueMoist Heat or Steam Sterilization