NDK — System, External Fixator (With Metallic Invasive Components) Class II

FDA Device Classification

FDA product code NDK covers "System, External Fixator (With Metallic Invasive Components)", a Class II medical device regulated under 21 CFR 888.3040. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.