510(k) K240875

Unity Knee PS-C Tibial Insert by Corin U.S.A. Limited — Product Code JWH

K240875 is an FDA 510(k) premarket notification submitted by Corin U.S.A. Limited for the device "Unity Knee PS-C Tibial Insert". The FDA issued a decision of Substantially Equivalent on June 26, 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. Corin U.S.A. Limited has at least 10 other 510(k) clearances on record.