510(k) K152825

Catalyst CSR Shoulder System by Catalyst Orthoscience, LLC — Product Code KWT

K152825 is an FDA 510(k) premarket notification submitted by Catalyst Orthoscience, LLC for the device "Catalyst CSR Shoulder System". The FDA issued a decision of Substantially Equivalent on May 11, 2016. The device falls under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3650. Catalyst Orthoscience, LLC has at least 10 other 510(k) clearances on record.