SPINOUS PROCESS FUSION (SPF) PLATE

SPINOUS PROCESS FUSION (SPF) PLATE is an FDA 510(k)-cleared medical device (K140046) manufactured by Spinal Simplicity, 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 January 8, 2015. Regulation: 8.