d21dc3d3-ef59-4a78-bd74-59da45fa1b95UpdatePublished22025-07-022019-11-05In Commercial Distribution04050659517455PrimaryGS1mahe medical GmbHPSS08-4525342243334mahe medical gmbh1Polyaxial screw, w/o cannulation, _x000D_4.5mm/25mm _x000D_falsefalsefalsefalsefalsetruetruetruefalsefalsetruefalsefalseLabeling does not contain MRI Safety Informationfalsefalse61325Bone-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.falseObsoleteNKBThoracolumbosacral pedicle screw systemfalsefalse