0ac64617-8b34-456a-903a-3bc979be4705NewPublished12018-06-212018-05-21In Commercial Distribution03700780602575PrimaryGS1Idys™- C0571410805714108296568400CLARIANCE1TRIAL falsefalsefalsefalsefalsefalsetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse7738687041s.chambat@clariance-spine.us44054Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.falseActiveOVDIntervertebral Fusion Device With Integrated Fixation, LumbarDepthWidthHeightfalsetrueMoist Heat or Steam Sterilization