{"publicDeviceRecordKey":"8b559762-d50b-4b1b-b083-0ea15e43af71","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-06-05T00:00:00.000Z","devicePublishDate":"2025-05-28T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00840194475136","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PNP Tibia","versionModelNumber":"00-1510-8265-S","catalogNumber":"00-1510-8265-S","dunsNumber":"796416191","companyName":"ORTHOPEDIATRICS CORP.","deviceCount":1,"deviceDescription":"PNP Tibia 8mm x 265mm Nail","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(574)268-6379","phoneExtension":null,"email":"xxx@xxx.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K250623","supplementNumber":"000"}]},"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":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}