510(k) K212356

Exactech® Equinoxe® Laser Cage Glenoid by Exactech, Inc. — Product Code KWS

K212356 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "Exactech® Equinoxe® Laser Cage Glenoid". The FDA issued a decision of Substantially Equivalent on March 4, 2022. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Exactech, Inc. has at least 10 other 510(k) clearances on record.