510(k) K260063

GSPE Spacer by The General Hospital Corporation, d/b/a Massachusetts — Product Code JWH

K260063 is an FDA 510(k) premarket notification submitted by The General Hospital Corporation, d/b/a Massachusetts for the device "GSPE Spacer". The FDA issued a decision of Substantially Equivalent on September 11, 2026. 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.