UNiTi ACDF Implant System

UNiTi ACDF Implant System is an FDA 510(k)-cleared medical device (K200301) manufactured by Pressio, 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 2, 2021. Regulation: 8.