21 CFR 888.3750 -

Regulations last checked for updates: May 02, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

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

§ 888.3750 -

(a) Identification. A wrist joint carpal lunate prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal lunate 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 888.3750