{"publicDeviceRecordKey":"e8fd8b2a-fb99-46d7-9c08-1d9f2ea97c37","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-01-27T00:00:00.000Z","devicePublishDate":"2026-01-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B1132R1NET20360","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Shoulder Innovations Inset Reverse Total Shoulder","versionModelNumber":"N22 Eccentric EZ Glenosphere - 36mm Diameter x 2mm Ecc x 0mm Lat","catalogNumber":"2R1NET2036","dunsNumber":"080404519","companyName":"Shoulder Innovations, Inc.","deviceCount":1,"deviceDescription":"Shoulder Innovations Inset Reverse Total Shoulder - N22 Eccentric EZ Glenosphere - 36mm Diameter x 2mm Ecc x 0mm Lat","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"616.294.1026","phoneExtension":null,"email":"info@shoulderinnovations.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35670","gmdnPTName":"Total shoulder prosthesis","gmdnPTDefinition":"A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.","implantable":true,"gmdnCodeStatus":"Active"},{"gmdnCode":"33711","gmdnPTName":"Total reverse shoulder prosthesis","gmdnPTDefinition":"A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treated by previous surgery. The device reverses normal anatomy so that the head portion of the joint is attached to the scapula and the socket portion is attached to the humerus. It typically includes a humeral stem and glenosphere (head) with body and cup components. The device may include screws for implantation and may be implanted with or without bone cement.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"PHX","productCodeName":"Shoulder Prosthesis, Reverse Configuration"},{"productCode":"MBF","productCodeName":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Radiation Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}