SeaSpine Regatta Lateral System

SeaSpine Regatta Lateral System is an FDA 510(k)-cleared medical device (K181079) 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 July 17, 2018. Regulation: 8.