ffb1e73d-ec6c-4065-8b5b-16be99ef2e61UpdatePublished32018-07-062016-07-07In Commercial Distribution06939488394872PrimaryGS1Multi-Axial Screw8214540545249039Shandong Weigao Orthopaedic Device Co., Ltd.1falsefalsefalsefalsefalsetruetruetruetruetruetruefalsefalseLabeling does not contain MRI Safety InformationtruefalseK16032000061325Bone-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 FixationKWPAppliance, Fixation, Spinal InterlaminalMNIOrthosis, Spinal Pedicle FixationfalsetrueMoist Heat or Steam Sterilization