{"publicDeviceRecordKey":"b20b8e55-f860-425a-97e8-fb19be8c765b","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2020-03-18T00:00:00.000Z","devicePublishDate":"2020-03-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"03607503402644","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"MADISON","versionModelNumber":"Universal UC insert Size 5 - 18 mm","catalogNumber":"340264","dunsNumber":"291993439","companyName":"IMPLANET","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":true,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K192084","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33664","gmdnPTName":"Cruciate-retaining total knee prosthesis","gmdnPTDefinition":"A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative (e.g., arthritic) joint [total knee arthroplasty (TKA)]; it is designed to be implanted with retention of the posterior cruciate ligament. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE). The device may be implanted with or without bone cement and is typically used in cases where bone stock is good and supporting ligaments provide adequate stability.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JWH","productCodeName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer"}]},"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}