b173c790-30c5-4b0e-8976-4c907464b025UpdatePublished52025-07-022020-06-25In Commercial Distribution00880304940468PrimaryGS1Polaris™ 4.75 Spinal System14-58109014-581090018577570BIOMET SPINE LLC1falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)447-3625USBROCustomerService@zimmerbiomet.com61325Bone-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.falseObsoleteKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALNKBThoracolumbosacral pedicle screw systemMNHOrthosis, spondylolisthesis spinal fixationOSHPedicle screw spinal system, adolescent idiopathic scoliosisMNIOrthosis, spinal pedicle fixationKWQAppliance, fixation, spinal intervertebral bodyDevice Size Text, specify4.75 TI 9MM MIDSTEM HOOKfalsetrueMoist Heat or Steam Sterilization