b624891a-62d2-4007-855c-7a2e15dc73fdUpdatePublished82026-03-202017-12-29In Commercial DistributionM555910151007PrimaryHIBCCValeo Spacer SystemD91.015.1007028629553SINTX Technologies, Inc.13/4" Flat CobbfalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsetrue801-839-3500customerservice@amedica.com61300Internal spinal fixation procedure kit, single-useA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device.falseActiveMAXIntervertebral Fusion Device With Bone Graft, LumbarfalsetrueMoist Heat or Steam Sterilization