{"publicDeviceRecordKey":"d2a38eb1-701c-4cb1-8700-9fb117011f14","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2025-07-14T00:00:00.000Z","devicePublishDate":"2020-05-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B8037101063","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"B803710106R0","pkgQuantity":6,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"TUBE"},{"deviceId":"B803710106R0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ORTHOMED","versionModelNumber":"OM 71-0106R","catalogNumber":"OM 71-0106R","dunsNumber":"086618626","companyName":"ORTHO-MED, INC.","deviceCount":1,"deviceDescription":"K-WIRE DBL.TROCAR PT. 5\" .035\" .9MM","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":false,"otc":false,"contacts":{"customerContact":[{"phone":"503-234-9691","phoneExtension":null,"email":"SUPPORT@ORTHOMEDINC.COM"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"32854","gmdnPTName":"Orthopaedic bone pin, non-bioabsorbable","gmdnPTDefinition":"A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HTY","productCodeName":"Pin, Fixation, Smooth"}]},"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":[]}}