Amedica Submits Response to FDA for Clearance of Composite Interbody Spinal Device
Amedica (AMDA) submitted its responses to FDA in relation to the CASCADE clinical trial.
CASCADE compared 24-month outcomes from single-level cervical fusion between AMDA's porous silicon nitride vs. autograft bone. Data indicated that porous silicon nitride achieved clinical and radiographic outcomes that were comparable to autograft.
AMDA expects a final determination from FDA within 60 days.
Source: Amedica Corporation