510(k) K243024

Cellbrick Knee Spacer by United Orthopedic Corporation — Product Code JWH

K243024 is an FDA 510(k) premarket notification submitted by United Orthopedic Corporation for the device "Cellbrick Knee Spacer". The FDA issued a decision of Substantially Equivalent on December 20, 2024. 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. United Orthopedic Corporation has at least 10 other 510(k) clearances on record.