§888.3770. Wrist joint carpal trapezium polymer prosthesis.
21 C.F.R. § 888.3770
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.
Classification. Class II.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.