SeaSpine Spinous Process System

SeaSpine Spinous Process System is an FDA 510(k)-cleared medical device (K173334) manufactured by SeaSpine Orthopedics Corporation. 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 21, 2018. Regulation: 8.