REVCON (TM) Screw System

REVCON (TM) Screw System is an FDA 510(k)-cleared medical device (K223392) manufactured by Voom Medical Devices, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 27, 2023. Regulation: 8.