{"publicDeviceRecordKey":"19a107c9-0b70-4842-b5d3-2622dc2f05f8","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-02-06T00:00:00.000Z","devicePublishDate":"2024-03-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033390260367","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PRIMA TT Glenoid","versionModelNumber":"1975.15.220","catalogNumber":"1975.15.220","dunsNumber":"432066322","companyName":"LIMACORPORATE SPA","deviceCount":1,"deviceDescription":"PRIMA TT Glenoid - Central Compressive Screw Cancellous Dia. 6,5 mm L. 20 mm\n","DMExempt":false,"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":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"66947","gmdnPTName":"Orthopaedic bone screw (non-sliding)","gmdnPTDefinition":"A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"PHX","productCodeName":"Shoulder Prosthesis, Reverse Configuration"},{"productCode":"MBF","productCodeName":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented"},{"productCode":"HSD","productCodeName":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented"},{"productCode":"KWS","productCodeName":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented"},{"productCode":"KWT","productCodeName":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented"},{"productCode":"PAO","productCodeName":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Dia. 6,5 mm L. 20 mm"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}