c5d41bb8-26a7-4046-806b-a7b53246c7b0NewPublished12024-11-122024-11-04In Commercial Distribution00763000675035PrimaryGS1TRANSLACE™ Spinal Tethering System8239000830350380MEDTRONIC SOFAMOR DANEK, INC.1TENSIONER 8239000 TENSIONERfalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)633-8766Corporate.UDI@medtronic.comK16318100044801Internal spinal fixation system cable tensionerA manual, hand-held surgical instrument used during orthopaedic surgery to apply an appropriate tension to a cable that is being implanted as part of a system to provide corrective surgery for the spine. The device is typically made of high-grade stainless steel, and is designed with a low intrusion profile to minimize the surgical exposure required for tightening the cables in situ. It will also be equipped with a means for accurate and reproducible tensioning of the cable(s). This is a reusable device.falseActiveOWIBone fixation cerclage, sublaminarfalsetrueMoist Heat or Steam Sterilization