0b8c0b43-2419-40e8-9814-a6867f8b76d3UpdatePublished52020-03-232016-09-20In Commercial DistributionB16740926400PrimaryHIBCCTALOSĀ® IBF4-092640182698477MEDITECH SPINE, LLC1falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK090707000K15078800060847Polymeric spinal fusion cage, sterileA 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.falseObsoleteMAXIntervertebral fusion device with bone graft, lumbartruefalse