21 CFR 882.5320

§ 882.5320 Preformed alterable cranioplasty plate.

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

Cite this

Citation: 21 CFR 882.5320, § 882.5320 Preformed alterable cranioplasty plate, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90726
Permanent ID: ys:prov:90726@1
SHA-256: db586823329088f8072cddc67500643173e2c4a463cf9b289c1e8c1cf23bd69d

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Full text

(a) Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material. (b) Classification. Class II (performance standards).

Legislative history

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