"The benefits of this new device include the potential for bone in-growth as well as on-growth, while a central lumen gives the surgeon flexibility to add bone graft, if needed."
I said that the surgeon can basically do what he wants about bone graft. It’s off label use if the surgeon does not use the graft. Amedica cannot market the product saying no bone graft is necessary as this goes against their 510k clearance instructions for use. We have a surgeon who uses a cervical plate for a wedge osteotomy in feet. Off label, but as long as it’s in the best interests of the patient. ANDA absolutely cannot market the device with no bone graft in the US
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