510(k) clearance for Spineart’s ROMEO2 PAD

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Spineart’s ROMEO2 PAD posterior axial device has received 510(k) clearance from the US Food and Drug Administration.

The device is a posterior non-pedicle supplemental fixation device intended for use as an adjunct to fusion in the lumbar spine. It features two plates and a central core and 30 degrees of plate poliaxiality.