Genesys Spine 3DP Lumbar Interbody System

Genesys Spine 3DP Lumbar Interbody System is an FDA 510(k)-cleared medical device (K182987) 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 December 11, 2019. Regulation: 8.