Parcus Synd-EZ SS

Parcus Synd-EZ SS is an FDA 510(k)-cleared medical device (K221502) manufactured by Parcus Medical, LLC. 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 25, 2022. Regulation: 8.