SeaSpine WaveForm™ A Interbody System

SeaSpine WaveForm™ A Interbody System is an FDA 510(k)-cleared medical device (K210583) 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 June 1, 2021. Regulation: 8.