Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws

Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws is an FDA 510(k)-cleared medical device (K223933) manufactured by Exactech, 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 September 24, 2023. Regulation: 8.