Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807).
1 1400sâ1800s (The Renaissance) â Copper, iron, steel, and wood were the most common materials used for prosthetics during this period.  1863 â During the American Civil War, the U.S. started to see advancements in the field of prosthetics.
A combination of plastic, carbon fiber, and other materials are used to create the prosthesis, Today, most prostheses are made from carbon fiber, resulting in them being lighter, stronger, and more reliable. Our team uses a variety of prosthetic componentry for below knee amputees. An evaluation is the first step in creating the most appropriate prosthesis for a particular patient.