510(k) K191318

AEQUALIS FLEX REVIVE Shoulder System by Tornier, Inc. — Product Code KWS

K191318 is an FDA 510(k) premarket notification submitted by Tornier, Inc. for the device "AEQUALIS FLEX REVIVE Shoulder System". The FDA issued a decision of Substantially Equivalent on June 14, 2019. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Tornier, Inc. has at least 10 other 510(k) clearances on record.