LGE — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing Class II

FDA Device Classification

FDA product code LGE covers "Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing", a Class II medical device regulated under 21 CFR 888.3530. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.