{"publicDeviceRecordKey":"1555029e-4661-410e-822f-4c5910623d54","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-05-28T00:00:00.000Z","devicePublishDate":"2026-05-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00193082166327","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ORIO-3D Cage System","versionModelNumber":"SP-LP-PT08-1426","catalogNumber":"SP-LP-PT08-1426","dunsNumber":"783908713","companyName":"SPINECRAFT, LLC","deviceCount":1,"deviceDescription":"ORIO-3D Trabecular Ti P-TLIF Cage, 9mm Wide, 14 x 26mm, 8 deg.","DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"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"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K253260","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38161","gmdnPTName":"Metallic spinal interbody fusion cage","gmdnPTDefinition":"A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OVD","productCodeName":"Intervertebral fusion device with integrated fixation, lumbar"},{"productCode":"ODP","productCodeName":"Intervertebral fusion device with bone graft, cervical"},{"productCode":"MAX","productCodeName":"Intervertebral fusion device with bone graft, lumbar"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}