eef99f33-5d49-43da-8364-068d954785b7NewPublished12025-12-022025-11-24In Commercial Distribution00810199190020PrimaryGS1ARKEO, Wedge Fixation System02-5205502-52055119185571Auxano Medical LLC1ARKEO Cotton Wedge Trial, 20x14x5.5falsefalsefalsefalsefalsefalsetruefalsetruefalsefalsefalsefalseMR Unsafetruefalse4402622000CS@AuxanoMedical.netK25179100061617Metallic 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)].trueActivePLFBone WedgefalsetrueMoist Heat or Steam Sterilization