Genesys Spine Binary® Lumbar Plate System

Genesys Spine Binary® Lumbar Plate System is an FDA 510(k)-cleared medical device (K192678) manufactured by Genesys Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 23, 2019. Regulation: 8.