Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage

Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is an FDA 510(k)-cleared medical device (K212792) manufactured by Medynus, 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 22, 2021. Regulation: 8.