{"publicDeviceRecordKey":"cbe911d8-5302-4f59-9568-4847938dbc24","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":"04026575234530","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Embrace Shoulder System","versionModelNumber":"641-075/22","catalogNumber":null,"dunsNumber":"315675488","companyName":"WALDEMAR LINK GmbH \u0026 Co. KG","deviceCount":1,"deviceDescription":null,"DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":false,"serialNumber":true,"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":"K212992","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34197","gmdnPTName":"Uncoated shoulder humeral stem prosthesis","gmdnPTDefinition":"A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"PHX","productCodeName":"shoulder prosthesis, reverse configuration"},{"productCode":"HSD","productCodeName":"PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED"},{"productCode":"PAO","productCodeName":"prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented"}]},"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}