510(k) K180743

Balanced Knee Revision System - Offset Junction Box by Ortho Development Corporation — Product Code JWH

K180743 is an FDA 510(k) premarket notification submitted by Ortho Development Corporation for the device "Balanced Knee Revision System - Offset Junction Box". The FDA issued a decision of Substantially Equivalent on June 20, 2018. 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. Ortho Development Corporation has at least 10 other 510(k) clearances on record.