Genesys Spine Binary Lumbar Plate System

Genesys Spine Binary Lumbar Plate System is an FDA 510(k)-cleared medical device (K173885) 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 April 2, 2018. Regulation: 8.