{"publicDeviceRecordKey":"75a51261-0cb6-4394-8d9e-c9b3009ae165","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-02-03T00:00:00.000Z","devicePublishDate":"2023-01-26T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04026575282968","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Link OptiStem","versionModelNumber":"17-1100/06","catalogNumber":null,"dunsNumber":"315675488","companyName":"WALDEMAR LINK GmbH \u0026 Co. KG","deviceCount":1,"deviceDescription":"Modular stem, uncemented, Ti6Al4V, oval","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":"K220628","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61561","gmdnPTName":"Body femoral/tibial extension stem, uncoated","gmdnPTDefinition":"A sterile implantable device intended to provide an extension of, or coupling with, other components of a modular femoral/tibial prosthesis in the medullary canal to compensate for bone loss during revision arthroplasty or bone resection. The device is a solid/dense body made of uncoated metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. Fixation devices for implantation (e.g., screws and bolts) may be included.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KRO","productCodeName":"PROSTHESIS, KNEE, FEMOROTIBIAL, 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}