99660b88-9945-4e05-b386-4024effe6197UpdatePublished42026-01-192019-08-23In Commercial Distribution08800033307136PrimaryGS14CIS® Chiron Spinal Fixation System4144-45354144-4535687844241ALPHA AI CO.,LTD.14CIS® Chiron Poly Axial Screw Ø4.5 X 35mm (Rod Ø5.5) falsefalsefalsefalsefalsetruetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK19047100061325Bone-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 SystemfalsetrueMoist Heat or Steam Sterilization