{"publicDeviceRecordKey":"8cffb46f-54ab-4288-8caf-b5b95b42c40f","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-02-09T00:00:00.000Z","devicePublishDate":"2026-01-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M719GSIX200L0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SIros-X","versionModelNumber":"1","catalogNumber":"GSI-X200-L","dunsNumber":"017921066","companyName":"Genesys Orthopedics Systems LLC","deviceCount":1,"deviceDescription":"SIros-X MIS Dilator, Large","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"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":"32338","gmdnPTName":"Fascial tissue dilator, reusable","gmdnPTDefinition":"A surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or surgical procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose at its distal end, that is available in a variety of sizes and made of metal (e.g., stainless steel). It is typically used for the dilatation of fascial tissue around peripheral vasculature, puncture sites, and various ducts. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OUR","productCodeName":"Sacroiliac Joint Fixation"},{"productCode":"OLO","productCodeName":"Orthopedic Stereotaxic Instrument"},{"productCode":"NKB","productCodeName":"Thoracolumbosacral Pedicle Screw System"}]},"deviceSizes":{"deviceSize":[]},"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}