NuVasive receives FDA clearance for cervical interbody implant system for more than two levels

NuVasive Inc. announced in a company press release that it has received FDA 510(k) clearance for the CoRoent small interbody system intended for intervertebral body fusion at multiple contiguous levels in the cervical spine.

The system reportedly is the first cervical cage cleared in the United States for use in up to four contiguous levels. The system is an interbody cage created from polyetheretherketone-optima and reportedly offers stabilization of the spinal motion segment during fusion. The hollow core can be filled with autogenous or allogeneic bone graft made of cancellous, cortical or corticocancellous bone graft material to promote fusion. The system includes titanium alloy or tantalum marker pins.

“This FDA 510(k) clearance is another key milestone for NuVasive as we continue to deliver new innovation to the spine market,” Jason Hannon, president and chief operating officer of NuVasive, said in the release. “The ability to treat multilevel cervical disc degeneration in patients displaying cervical radiculopathy and myelopathy is a meaningful advancement for spine surgeons. This first and only clearance is an example of NuVasive’s commitment to defining the components necessary to properly address an unmet clinical need and expand our presence and competitive positioning in the cervical market.”

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