5b7f7ab8-c343-483f-a967-ae17b7e85075UpdatePublished42019-10-042015-09-24In Commercial Distribution10705034158860PrimaryGS1MOUNTAINEER188362027188362027482661753Medos International Sàrl1MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 27mmfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)255-2500xx@xx.xxK042508000K151885000K19089500061325Bone-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.trueActiveKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALMNIORTHOSIS, SPINAL PEDICLE FIXATIONNKGOrthosis, cervical pedicle screw spinal fixationfalsetrueMoist Heat or Steam Sterilization