510(k) K182500

Catalyst CSR Press-Fit Humeral Components by Catalyst Orthoscience, Inc. — Product Code KWT

K182500 is an FDA 510(k) premarket notification submitted by Catalyst Orthoscience, Inc. for the device "Catalyst CSR Press-Fit Humeral Components". The FDA issued a decision of Substantially Equivalent on January 11, 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. Catalyst Orthoscience, Inc. has at least 10 other 510(k) clearances on record.