Code of Federal Regulations · Section
§ 888.3750 — Wrist Joint Carpal Lunate Polymer Prosthesis
21 C.F.R. § 888.3750
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(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.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351