Code of Federal Regulations · Section
§ 888.3770 — Wrist Joint Carpal Trapezium Polymer Prosthesis
21 C.F.R. § 888.3770
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(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.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351