Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161

Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 is an FDA 510(k)-cleared medical device (K201072) manufactured by Ensemble Orthopedics, 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 December 1, 2020. Regulation: 8.