{"publicDeviceRecordKey":"6f650e84-2755-4390-8757-a9df5c38c839","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-04-03T00:00:00.000Z","devicePublishDate":"2019-03-26T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M7401001028","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Duo Lumbar Interbody Fusion System","versionModelNumber":"101-56-02-12","catalogNumber":"100-1028","dunsNumber":"033014361","companyName":"SPINEOLOGY INC.","deviceCount":1,"deviceDescription":"Duo Trial, 12mm, 8°","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(651)256-8500","phoneExtension":"513","email":"aadams@spineology.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K182322","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"60847","gmdnPTName":"Polymeric spinal fusion cage, sterile","gmdnPTDefinition":"A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Fixation screws and disposable devices associated with implantation may be included with the device.","implantable":false,"gmdnCodeStatus":"Obsolete"},{"gmdnCode":"61609","gmdnPTName":"Vertebral body bone graft pouch","gmdnPTDefinition":"A sterile, implantable, mesh bag designed to contain and maintain the position of bone graft materials that have been implanted into a vertebral body defect, following bone tissue removal, to treat defects typically caused by trauma, deformity, tumours, or degenerative diseases. It is made of woven/knitted non-bioabsorbable synthetic polymer(s) material. Dedicated disposable devices associated with implantation may be included.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MAX","productCodeName":"Intervertebral fusion device with bone graft, lumbar"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"8° Lordosis"},{"sizeType":"Height","size":{"unit":"Millimeter","value":"12"},"sizeText":null,"sizeString":"Height: 12 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}