{"publicDeviceRecordKey":"09adbc6f-af52-4b4c-806e-abe73faba520","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2021-03-15T00:00:00.000Z","devicePublishDate":"2021-01-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04048844205331","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Uni FB tibial component LL/RM","versionModelNumber":"40100012","catalogNumber":null,"dunsNumber":"324369826","companyName":"implantcast GmbH","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":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"48068","gmdnPTName":"Uncoated unicondylar knee tibia prosthesis, metallic","gmdnPTDefinition":"A sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability. The device articulates with a femoral component and an insert, and its implantation is intended to be performed with bone cement.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HSX","productCodeName":"Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"2"}]},"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":[]}}