{"publicDeviceRecordKey":"1623c5a8-77c8-45cd-b581-0c834d866f22","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2023-03-13T00:00:00.000Z","devicePublishDate":"2015-11-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04026575043989","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Unicondylar Sled Prosthesis","versionModelNumber":"15-2028/06","catalogNumber":"15-2028/06","dunsNumber":"315675488","companyName":"WALDEMAR LINK GmbH \u0026 Co. KG","deviceCount":1,"deviceDescription":"Tibia Plateau,all-polyethylene\n","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":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K954186","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"48069","gmdnPTName":"Uncoated unicondylar knee tibia prosthesis, polyethylene","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 polyethylene (PE) and is not coated with a material intended to improve fixation and stability. The device articulates with a femoral component, 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":[]},"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}