{"publicDeviceRecordKey":"d6a18658-a671-477c-89df-bfa0e6ff1e08","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":8,"publicVersionDate":"2026-03-20T00:00:00.000Z","devicePublishDate":"2017-12-29T00:00:00.000Z","deviceCommDistributionEndDate":"2023-09-27T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M555126001007","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Valeo Spacer System","versionModelNumber":"F","catalogNumber":"12.600.1007","dunsNumber":"028629553","companyName":"SINTX Technologies, Inc.","deviceCount":1,"deviceDescription":"VII C 14x12 0degrees 7mm","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":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"801-839-3500","phoneExtension":null,"email":"customerservice@amedica.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61958","gmdnPTName":"Ceramic 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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of a ceramic material [e.g., silicon nitride] 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 included with the device.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MAX","productCodeName":"Intervertebral Fusion Device With Bone Graft, Lumbar"},{"productCode":"ODP","productCodeName":"Intervertebral Fusion Device With Bone Graft, Cervical"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Height","size":{"unit":"Millimeter","value":"7"},"sizeText":null,"sizeString":"Height: 7 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Radiation Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}