{"publicDeviceRecordKey":"9d4b7450-4e47-4fa1-87ca-07f48a616ee0","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-03-11T00:00:00.000Z","devicePublishDate":"2025-03-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08050880237708","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Pantheon System","versionModelNumber":"Salvage Stem (Uncemented)","catalogNumber":"0200513","dunsNumber":"338847291","companyName":"ADLER ORTHO SPA","deviceCount":1,"deviceDescription":"Pantheon Salvage Cementless Stem L 115 Ø 13","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":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34038","gmdnPTName":"Revision uncoated femoral stem prosthesis","gmdnPTDefinition":"A sterile implantable device designed to replace the proximal femoral neck during replacement of a total hip prosthesis typically due to wear. The device is composed of two or more separate segments designed to be joined (modular), is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included; implantation is intended to be performed with bone cement and may involve use of a femoral extension.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LPH","productCodeName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented"},{"productCode":"JDI","productCodeName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented"},{"productCode":"LZO","productCodeName":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented"},{"productCode":"MBL","productCodeName":"Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"L115mm, Diameter 13mm"}]},"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":[]}}