Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw

K162325 is the FDA 510(k) clearance record for Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw, a class II device, cleared for Exactech, Inc. on 2017-03-06 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 no recalls naming K162325.