e-CFR data is current as of February 23, 2021 |
Title 21 → Chapter I → Subchapter H → Part 888 → Subpart D → §888.3770 |
Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices
(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.