e474b2a3-dc07-4314-823d-c882f05ff610NewPublished12020-10-062020-09-28In Commercial Distribution00763000333393PrimaryGS1Translace™ Spinal Tethering System9010007013830350380MEDTRONIC SOFAMOR DANEK, INC.1TETHER 9010007013 0.3MM INSERT ASSEMBLYfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)633-8766Corporate.UDI@medtronic.comK16318100046242Surgical support tape, non-bioabsorbableA band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device.trueActiveOWIBone fixation cerclage, sublaminarDevice Size Text, specifyThicktruefalse