Spineart's ROMEO2 PAD Posterior Axial Device received 510(k) clearance from the U. S. 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.
Spineart is a privately held medical device company focused on the fields of minimally invasive surgery, motion preservation, fusion, biologics and fracture treatment.
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