4c8c53da-39af-499c-abba-26b874cc9622NewPublished12025-05-282025-05-20In Commercial Distribution00840097528014PrimaryGS1Ossera™ AFX1740-4248-N080819836Restor3d, Inc.1Ossera™ AFX, Cylinder, 42x48falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseMR UnsafetruefalseK24235600061617Metallic osteotomy fusion cage, non-customized A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)].trueActiveSAIAnkle Fusion CagefalsetrueMoist Heat or Steam Sterilization