510(k) K192365

Shoulder Innovations Total Shoulder System by Shoulder Innovations, Inc. — Product Code KWT

K192365 is an FDA 510(k) premarket notification submitted by Shoulder Innovations, Inc. for the device "Shoulder Innovations Total Shoulder System". The FDA issued a decision of Substantially Equivalent on November 29, 2019. The device falls under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3650. Shoulder Innovations, Inc. has at least 10 other 510(k) clearances on record.