Parcus Synd-EZ Ti

Parcus Synd-EZ Ti is an FDA 510(k)-cleared medical device (K191783) 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 October 8, 2019. Regulation: 8.