9e5b3b37-ac13-451e-9130-0ce4bae6714cUpdatePublished22021-11-232019-11-07In Commercial Distribution00190837033859PrimaryGS1External Fixation114-383-3114-383-3183641617Life Spine, Inc.1Tray3 MiddlefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK17388300048011External orthopaedic fixation system, single-useAn assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.trueActiveKTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENTfalsetrueMoist Heat or Steam Sterilization