a7c85142-f45b-4e24-8c19-78d76d0abd5cUpdatePublished42024-09-092016-06-06In Commercial Distribution00190837006433PrimaryGS1Nautilus Spinal System650-090183641617Life Spine, Inc.1falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK11195300065115Bone-screw internal spinal fixation system hookAn implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.trueActiveNKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc DiseasefalsetrueMoist Heat or Steam Sterilization