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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

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