510(k) K183533

Unity Total Knee System by Corin U.S.A. Limited — Product Code JWH

K183533 is an FDA 510(k) premarket notification submitted by Corin U.S.A. Limited for the device "Unity Total Knee System". The FDA issued a decision of Substantially Equivalent on June 4, 2019. 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. Corin U.S.A. Limited has at least 10 other 510(k) clearances on record.