{"publicDeviceRecordKey":"a0dfc413-09aa-4df3-91ef-d4c645453699","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-01-26T00:00:00.000Z","devicePublishDate":"2026-01-18T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M719GSIXFC0950700","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SIros-X","versionModelNumber":"1","catalogNumber":"GSI-XFC095070","dunsNumber":"017921066","companyName":"Genesys Orthopedics Systems LLC","deviceCount":1,"deviceDescription":"9.5mm x 70mm SIros-X FA Low Top Closed Screw Assembly","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":"5123817070","phoneExtension":null,"email":"info@genesysspine.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K252322","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"},{"gmdnCode":"46651","gmdnPTName":"Spinal bone screw, non-bioabsorbable","gmdnPTDefinition":"A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OUR","productCodeName":"Sacroiliac Joint Fixation"},{"productCode":"NKB","productCodeName":"Thoracolumbosacral Pedicle Screw System"},{"productCode":"OLO","productCodeName":"Orthopedic Stereotaxic Instrument"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"70"},"sizeText":null,"sizeString":"Length: 70 Millimeter"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"9.5"},"sizeText":null,"sizeString":"Outer Diameter: 9.5 Millimeter"}]},"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}