510(k) K190521

Aequalis Ascend Flex Shoulder System by Tornier S.A.S. — Product Code KWS

K190521 is an FDA 510(k) premarket notification submitted by Tornier S.A.S. for the device "Aequalis Ascend Flex Shoulder System". The FDA issued a decision of Substantially Equivalent on June 12, 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 S.A.S. has at least 10 other 510(k) clearances on record.