DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM

DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM is an FDA 510(k)-cleared medical device (K162212) 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 May 18, 2017. Regulation: 8.