MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

MAXFRAME Multi-Axial Correction System (aka MAXFRAME) is an FDA 510(k)-cleared medical device (K211313) manufactured by Synthes (USA) 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 May 24, 2021. Regulation: 8.