21 CFR 888.3780

§ 888.3780 Wrist joint polymer constrained prosthesis.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 888.3780, § 888.3780 Wrist joint polymer constrained prosthesis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91129
Permanent ID: ys:prov:91129@1
SHA-256: ee0a8372f51fd028ed1b9b55d540d9c01a1a608f3d3ee7775d62ec2029d5f721

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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.