ShurFit Lumbar Interbody System

ShurFit Lumbar Interbody System is an FDA 510(k)-cleared medical device (K212075) manufactured by Precision Spine, 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 December 7, 2021. Regulation: 8.