Code of Federal Regulations · Section
§ 888.3780 — Wrist Joint Polymer Constrained Prosthesis
21 C.F.R. § 888.3780
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(a) Identification. A wrist joint polymer constrained prosthesis is a device made of polyester-reinforced silicone elastomer intended to be implanted to replace a wrist joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.
(b) Classification. Class II.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351