c0d37a1e-594d-4e5a-920e-e3ea38febf41UpdatePublished32018-07-062016-09-24In Commercial Distribution00190361034483PrimaryGS1PedFuse01-80164-5545002003243SPINEFRONTIER, INC.1Straight Pedicle Rod CoCr Ø5.5 X 45MMtruefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(866)914-7717customerservice@spinefrontier.comK13315300061325Bone-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.trueActiveMNHOrthosis, spondylolisthesis spinal fixationMNIORTHOSIS, SPINAL PEDICLE FIXATIONLengthOuter DiameterfalsetrueMoist Heat or Steam Sterilization