{"publicDeviceRecordKey":"517dce01-4924-4d42-987b-b28efec34cf9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2026-02-09T00:00:00.000Z","devicePublishDate":"2017-02-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M69601IM300","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"OIC Intramedullary Nail System","versionModelNumber":"01-IM30","catalogNumber":null,"dunsNumber":"070061160","companyName":"ORTHOPAEDIC IMPLANT COMPANY, THE","deviceCount":1,"deviceDescription":"IMPACTOR IM NAIL ","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"775 636 8281","phoneExtension":null,"email":"Info@OrthoImplantCompany.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K150655","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"32856","gmdnPTName":"Orthopaedic implant impactor, reusable","gmdnPTDefinition":"A non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HSB","productCodeName":"Rod, Fixation, Intramedullary And Accessories"}]},"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}