{"publicDeviceRecordKey":"8af1abca-4755-45cd-839d-f41def3a8aec","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":8,"publicVersionDate":"2025-01-03T00:00:00.000Z","devicePublishDate":"2017-05-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"03662663025720","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"VFT","versionModelNumber":"VF3327P","catalogNumber":"VF3327P","dunsNumber":"615789729","companyName":"LDR Spine Usa, Inc.","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"800-699-3360","phoneExtension":null,"email":"custserv@ldrspine.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34170","gmdnPTName":"Vertebral body prosthesis","gmdnPTDefinition":"An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MQP","productCodeName":"Spinal Vertebral Body Replacement Device"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Height","size":{"unit":"Millimeter","value":"82"},"sizeText":null,"sizeString":"Height: 82 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}