WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System

WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System is an FDA 510(k)-cleared medical device (K201755) 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 December 14, 2020. Regulation: 8.