Exactech Equinoxe Humeral Augmented Trays

K191561 is the FDA 510(k) clearance record for Exactech Equinoxe Humeral Augmented Trays, a class II device, cleared for Exactech, Inc. on 2019-08-20 under FDA product code PHX (Shoulder Prosthesis, Reverse Configuration). FDA's definition for product code PHX reads: "Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a...". FDA records list 186 510(k) clearances for Exactech, Inc., from 1986-10-15 to 2026-04-14. As of 2026-09-10, FDA records show one recall naming K191561.