{"publicDeviceRecordKey":"a23e98ee-3ef7-4acb-9031-d64dd0491315","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2024-12-11T00:00:00.000Z","devicePublishDate":"2019-11-07T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00190837063030","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Simpact Tri-Fin","versionModelNumber":"152-164","catalogNumber":"152-164","dunsNumber":"183641617","companyName":"Life Spine, Inc.","deviceCount":1,"deviceDescription":"Parallel Pin Offset Guide, Large Screw","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":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47870","gmdnPTName":"Orthopaedic fixation implant alignment tool","gmdnPTDefinition":"A surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OUR","productCodeName":"Sacroiliac joint fixation"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}