HD Lumbar Interbody System

HD Lumbar Interbody System is an FDA 510(k)-cleared medical device (K170676) manufactured by Hd Lifesciences, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 12, 2017. Regulation: 8.