StacksVerified U.S. regulatory reference

21 CFR §888.3770

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (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.
  2. (b)Classification. Class II.