{"publicDeviceRecordKey":"dfb919d2-81e7-45af-89f5-aa270b892572","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2024-11-20T00:00:00.000Z","devicePublishDate":"2015-10-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M697X07705151","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Fortex Pedicle Screw System","versionModelNumber":"X077-0515","catalogNumber":null,"dunsNumber":"081224143","companyName":"Xtant Medical Holdings, Inc.","deviceCount":1,"deviceDescription":"CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 140mm","DMExempt":true,"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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(888)886-9354","phoneExtension":null,"email":"cs@xtantmedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K090224","supplementNumber":"000"},{"submissionNumber":"K120832","supplementNumber":"000"},{"submissionNumber":"K152132","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"65116","gmdnPTName":"Bone-screw internal spinal fixation system rod","gmdnPTDefinition":"An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MNH","productCodeName":"Orthosis, spondylolisthesis spinal fixation"},{"productCode":"MNI","productCodeName":"Orthosis, spinal pedicle fixation"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"140"},"sizeText":null,"sizeString":"Length: 140 Millimeter"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"5.5"},"sizeText":null,"sizeString":"Outer Diameter: 5.5 Millimeter"}]},"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}