Joint, Elbow, External Limb Component, Mechanical

What Is FDA Product Code IRD?

Joint, Elbow, External Limb Component, Mechanical is FDA product code IRD, Class 1, 21 CFR 890.3420.

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.