510(k) K201072

Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 by Ensemble Orthopedics, LLC — Product Code KYI

K201072 is an FDA 510(k) premarket notification submitted by Ensemble Orthopedics, LLC for the device "Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161". The FDA issued a decision of Substantially Equivalent on December 2, 2020. The device falls under product code KYI (Prosthesis, Wrist, Carpal Trapezium), a Class II device regulated under 21 CFR 888.3770.