21 CFR § 888.3770
Wrist joint carpal trapezium polymer prosthesis
June 25, 2020
(a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.
(b) Classification. Class II.