{"publicDeviceRecordKey":"e91bcc26-eb39-4681-9773-3f9baa03ce9f","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2023-12-15T00:00:00.000Z","devicePublishDate":"2021-09-17T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B648C61495SC0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SI-LUTION Sacroiliac Joint Fusion System","versionModelNumber":"C614-95-SC","catalogNumber":null,"dunsNumber":"074575332","companyName":"CURITEVA, INC.","deviceCount":1,"deviceDescription":"Stabilization Cap, Static, 9.5mm","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1 (877) 928-7483","phoneExtension":null,"email":"support@curiteva.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K210402","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61485","gmdnPTName":"Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated","gmdnPTDefinition":"An implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OUR","productCodeName":"Sacroiliac Joint Fixation"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"9.5mm"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}