PIVOX(tm) Oblique Lateral Spinal System

PIVOX(tm) Oblique Lateral Spinal System is an FDA 510(k)-cleared medical device (K152277) manufactured by Medtronic Sofamor Danek USA, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 2015. Regulation: 8.