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21 CFR 888.3750

§ 888.3750 Wrist joint carpal lunate polymer prosthesis.

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

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21 CFR 888.3750, § 888.3750 Wrist joint carpal lunate polymer prosthesis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91126
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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.

Legislative history

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