FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA Clears Standalone Cervical Interbody Fusion System

Aug. 15, 2019
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Nexxt Spine’s Nexxt Matrixx standalone cervical system has received 510(k) clearance from the FDA, giving the device the go-ahead for marketing.

The device, an anterior cervical interbody fusion system, is intended for use as an adjunct to fusion for treating degenerative disc disease, defined as discogenic neck pain with disc degeneration confirmed by history and radiography.

The system is used with autograft bone graft and/or allogeneic bone graft made of cancellous and/or corticocancellous bone. It comes with its own bone screw fixation and needs no additional fixation.

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