1f44bb32-e8c8-4ddd-91bd-d05753594005UpdatePublished52025-07-022017-11-25In Commercial Distribution08809255540468PrimaryGS1Galaxy Mis Screw SystemGC300-5565557799209BM KOREA CO., LTD1The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. falsefalsefalsefalsefalsetruetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK14311000061325Bone-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.falseObsoleteMNHOrthosis, Spondylolisthesis Spinal FixationMNIOrthosis, Spinal Pedicle FixationNKBThoracolumbosacral Pedicle Screw SystemLengthOuter DiameterfalsetrueMoist Heat or Steam Sterilization