62b0b346-1e9d-49e2-a216-8dd3d86e0325UpdatePublished32018-07-062016-09-032016-09-08Not in Commercial Distribution06937762164784PrimaryGS1KangLi Pedicle Screw Spinal SystemT6160110T6160110527054774Suzhou Kangli Orthopaedics Instrument Co.,Ltd.1Rod (φ6.0)falsefalsefalsefalsefalsetruetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK14229000061325Bone-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 FixationDevice Size Text, specifyDiameter: 6.0 mmLengthtruetrueMoist Heat or Steam Sterilization