{"publicDeviceRecordKey":"8dd519e3-f973-4fb4-803d-44c8d3cc8e71","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":7,"publicVersionDate":"2025-02-06T00:00:00.000Z","devicePublishDate":"2015-09-28T00:00:00.000Z","deviceCommDistributionEndDate":"2024-09-01T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M824FS140161","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ALTUM","versionModelNumber":"FS1-4016","catalogNumber":null,"dunsNumber":"783908713","companyName":"SPINECRAFT, LLC","deviceCount":1,"deviceDescription":"ALTUM ACP Screw - Fixed, 4.0mm, 16mm","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":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(630)920-7300","phoneExtension":null,"email":"info@spinecraft.com"},{"phone":"+1(999)999-1112","phoneExtension":null,"email":"info@device.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K103505","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":"KWQ","productCodeName":"APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY"}]},"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}