510(k) K222570

COPAL knee moulds by Heraeus Medical GmbH — Product Code JWH

K222570 is an FDA 510(k) premarket notification submitted by Heraeus Medical GmbH for the device "COPAL knee moulds". The FDA issued a decision of Substantially Equivalent on February 4, 2023. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Heraeus Medical GmbH has at least 10 other 510(k) clearances on record.