{"publicDeviceRecordKey":"656a2390-c47d-4217-94c5-4d8dc2f4b7c8","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2025-10-24T00:00:00.000Z","devicePublishDate":"2016-09-16T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"18032568037814","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Stainless Steel Tibial Nailing System","versionModelNumber":"1","catalogNumber":"74835","dunsNumber":"438793622","companyName":"ORTHOFIX SRL","deviceCount":1,"deviceDescription":"SOLID TIBIAL NAIL DIAMETER 8 MM LENGTH  350 MM\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+039456719000","phoneExtension":null,"email":"info@orthofix.it"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38152","gmdnPTName":"Tibia intramedullary nail","gmdnPTDefinition":"A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HSB","productCodeName":"Rod, Fixation, Intramedullary And Accessories"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}