{"publicDeviceRecordKey":"e7627a12-00c2-492d-ab83-7e7f5a0bf908","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2026-01-28T00:00:00.000Z","devicePublishDate":"2024-02-22T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00810112594331","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"TriLeap Lower Extremity Anatomic Plating System","versionModelNumber":"3.0 mm Ti Variable Angle Screw Length 18 mm, Rose Red","catalogNumber":"04.908.018","dunsNumber":"058864308","companyName":"CROSSROADS EXTREMITY SYSTEMS","deviceCount":1,"deviceDescription":"3.0 mm Ti Variable Angle Screw Length 18 mm, Rose Red\n","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":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K230591","supplementNumber":"000"},{"submissionNumber":"K253178","supplementNumber":"000"}]},"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":"HRS","productCodeName":"Plate, Fixation, Bone"},{"productCode":"HWC","productCodeName":"Screw, Fixation, Bone"}]},"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}