PRESSON SPINAL FIXATION SYSTEM

PRESSON SPINAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K133287) manufactured by Nexus Spine, 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 February 24, 2014. Regulation: 8.