Zavation VariSync Plate System and VariSync Spacer System

Zavation VariSync Plate System and VariSync Spacer System is an FDA 510(k)-cleared medical device (K221049) manufactured by Zavation Medical Products, 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 August 11, 2022. Regulation: 8.