Lateralized and Augmented Baseplates

Lateralized and Augmented Baseplates is an FDA 510(k)-cleared medical device (K210790) manufactured by Fx Shoulder USA, 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 August 24, 2021. Regulation: 8.