What Is This Device?
Prosthesis modification instrument for ossicular replacement surgery; see product code JXY.
How Is NNO Classified?
Jig, Piston Cutting, Ent, Non-Sterile is FDA product code NNO, Class 1, 21 CFR 874.3540.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.