{"publicDeviceRecordKey":"bf4729c3-0137-4d74-b347-0434f6324096","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2024-04-09T00:00:00.000Z","devicePublishDate":"2024-04-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00822409123773","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Trivicta","versionModelNumber":"513-1012","catalogNumber":null,"dunsNumber":"876542390","companyName":"Ortho Development Corporation","deviceCount":1,"deviceDescription":"Collarless EXT Size 12","DMExempt":true,"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":"+1(801)553-9991","phoneExtension":null,"email":"customerservice@odev.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"55834","gmdnPTName":"Press-fit hip femur prosthesis, one-piece","gmdnPTDefinition":"A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck. The device is one-piece and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LPH","productCodeName":"PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED"},{"productCode":"MEH","productCodeName":"Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate"},{"productCode":"KWL","productCodeName":"Prosthesis, hip, hemi-, femoral, metal"},{"productCode":"LZO","productCodeName":"Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}