{"publicDeviceRecordKey":"29190344-783e-4e04-9ae7-7d6a20ece8d0","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2021-05-05T00:00:00.000Z","devicePublishDate":"2016-11-28T00:00:00.000Z","deviceCommDistributionEndDate":"2021-05-04T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M7403663512","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Rampart T Lumbar Interbody Fusion Device","versionModelNumber":"10-10-72-16","catalogNumber":"366-3512","dunsNumber":"033014361","companyName":"SPINEOLOGY INC.","deviceCount":1,"deviceDescription":"Spinal Implant","DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(651)256-8500","phoneExtension":"534","email":"jhauge@spineology.com"}]},"gmdnTerms":{"gmdn":[{"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":"Length","size":{"unit":"Millimeter","value":"12"},"sizeText":null,"sizeString":"Length: 12 Millimeter"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"12x35"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Ethylene Oxide"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}