bb799fc3-2125-4aec-ab59-a49de8e6ccb4UpdatePublished22021-06-082019-11-07In Commercial Distribution00190837063535PrimaryGS1Tarsa-Link Wedge Fixation System114-160114-160183641617Life Spine, Inc.1falsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK15036800061330Polymeric osteotomy fusion cage, non-customizedA non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia) following osteotomy to help facilitate bone fusion and alignment; it is typically 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 synthetic polymer [e.g., polyetheretherketone (PEEK)].trueActiveHRSPlate, fixation, bonefalsetrueMoist Heat or Steam Sterilization