21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024

View all text of Subpart D [§ 888.3000 - § 888.3810]

§ 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

(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.

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.

cite as: 21 CFR 888.3770