d6a18658-a671-477c-89df-bfa0e6ff1e08UpdatePublished82026-03-202017-12-292023-09-27Not in Commercial DistributionM555126001007PrimaryHIBCCValeo Spacer SystemF12.600.1007028629553SINTX Technologies, Inc.1VII C 14x12 0degrees 7mmfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse801-839-3500customerservice@amedica.com61958Ceramic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of a ceramic material [e.g., silicon nitride] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.trueActiveMAXIntervertebral Fusion Device With Bone Graft, LumbarODPIntervertebral Fusion Device With Bone Graft, CervicalHeighttruetrueRadiation Sterilization