{"publicDeviceRecordKey":"11d28017-312c-489c-a874-c4148de3fcf2","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2025-07-14T00:00:00.000Z","devicePublishDate":"2016-09-27T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"1199029","deviceIdType":"Direct Marking","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"M364119902FD90","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Asfora Bullet Cage® System  ","versionModelNumber":"11-9902-FD9","catalogNumber":null,"dunsNumber":"003815548","companyName":"MEDICAL DESIGNS  LLC","deviceCount":1,"deviceDescription":"18mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"605-275-1032","phoneExtension":null,"email":"kspielman@medicaldeisgnsllc.com"}]},"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":"MAX","productCodeName":"Intervertebral Fusion Device With Bone Graft, Lumbar"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"18"},"sizeText":null,"sizeString":"Outer Diameter: 18 Millimeter"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"21"},"sizeText":null,"sizeString":"Length: 21 Millimeter"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}