Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 888  /  Sec. 888.3760 Wrist joint carpal scaphoid polymer prosthesis.

(a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal scaphoid bone of the wrist.

(b) Classification. Class II.