{"publicDeviceRecordKey":"b99f74e8-89c1-4e56-9b98-90e5003955d7","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2020-02-24T00:00:00.000Z","devicePublishDate":"2015-10-27T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00889095217841","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"FORTIFY","versionModelNumber":"351.381","catalogNumber":null,"dunsNumber":"139105691","companyName":"GLOBUS MEDICAL, INC.","deviceCount":1,"deviceDescription":"FORTIFY-R 14mm Lower Endplate, 16x20mm Footprint, 0deg","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+1(610)930-1800","phoneExtension":null,"email":"info@globusmedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K112756","supplementNumber":"000"}]},"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":"Width","size":{"unit":"Millimeter","value":"20"},"sizeText":null,"sizeString":"Width: 20 Millimeter"},{"sizeType":"Depth","size":{"unit":"Millimeter","value":"16"},"sizeText":null,"sizeString":"Depth: 16 Millimeter"}]},"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}