{"publicDeviceRecordKey":"e713341b-d558-415e-840f-fe1b62ef9653","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-10-02T00:00:00.000Z","devicePublishDate":"2019-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08800036802829","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"CentLoc Total Knee System","versionModelNumber":"7132-0110","catalogNumber":"7132-0110","dunsNumber":"694670830","companyName":"RootLoc Co., Ltd.","deviceCount":1,"deviceDescription":"CentLoc Tibial insert component CR type Size1 10mm","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K182370","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61559","gmdnPTName":"Femur/tibia shaft prosthesis","gmdnPTDefinition":"A sterile implantable device designed to replace the shaft (body) of the femur/tibia following resection of the femur/tibia (e.g., due to tumour). It typically connects proximally to a femoral stem prosthesis or knee tibia prosthesis and distally to a sleeve femoral/tibial extension, knee femur prosthesis, or body femoral/tibial extension stem; it is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. Disposable devices associated with implantation may be included.","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}