WaveForm L System, WaveForm TO System, WaveForm TA System

WaveForm L System, WaveForm TO System, WaveForm TA System is an FDA 510(k)-cleared medical device (K213420) 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 May 3, 2022. Regulation: 8.