{"publicDeviceRecordKey":"c5d41bb8-26a7-4046-806b-a7b53246c7b0","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2024-11-12T00:00:00.000Z","devicePublishDate":"2024-11-04T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00763000675035","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"TRANSLACE™ Spinal Tethering System","versionModelNumber":"8239000","catalogNumber":null,"dunsNumber":"830350380","companyName":"MEDTRONIC SOFAMOR DANEK, INC.","deviceCount":1,"deviceDescription":"TENSIONER 8239000 TENSIONER","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)633-8766","phoneExtension":null,"email":"Corporate.UDI@medtronic.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K163181","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44801","gmdnPTName":"Internal spinal fixation system cable tensioner","gmdnPTDefinition":"A 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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OWI","productCodeName":"Bone fixation cerclage, sublaminar"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}