{"publicDeviceRecordKey":"6d91b477-dcad-4d46-81a9-43db53b42577","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2025-05-28T00:00:00.000Z","devicePublishDate":"2015-10-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00812258024451","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PRECICE® Intramedullary Limb Lengthening System","versionModelNumber":"PR12.5-80B365","catalogNumber":"PR12.5-80B365","dunsNumber":"837845234","companyName":"NUVASIVE SPECIALIZED ORTHOPEDICS, INC.","deviceCount":1,"deviceDescription":"Orthopedic intramedullary limb lengthening rod, antegrade femur piriformis, 12.5 mm diameter, 365 mm length","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 Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"866-456-2871","phoneExtension":null,"email":"info@globusmedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33187","gmdnPTName":"Femur intramedullary nail","gmdnPTDefinition":"A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the femur 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 may include 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":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"12.5"},"sizeText":null,"sizeString":"Outer Diameter: 12.5 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":[]}}