{"publicDeviceRecordKey":"eb30e713-bc15-4305-8df4-5026fb2acbe0","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2024-09-23T00:00:00.000Z","devicePublishDate":"2018-10-26T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M697X06015201","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"M697X06015200","deviceIdType":"Direct Marking","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Axle Interspinous Fusion System","versionModelNumber":"X060-1520","catalogNumber":null,"dunsNumber":"081224143","companyName":"Xtant Medical Holdings, Inc.","deviceCount":1,"deviceDescription":"PLIERS ALL-IN-ONE, INSERTER/COMPRESSOR, ASSEMBLY","DMExempt":false,"premarketExempt":true,"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":[{"phone":"+1(888)886-9354","phoneExtension":null,"email":"cs@xtantmedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47127","gmdnPTName":"Lumbar interspinous decompression instrument set, reusable","gmdnPTDefinition":"A collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HTC","productCodeName":"Pliers, Surgical"}]},"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":[]}}