21 CFR 882.5300

§ 882.5300 Methyl methacrylate for cranioplasty.

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

Cite this

Citation: 21 CFR 882.5300, § 882.5300 Methyl methacrylate for cranioplasty, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90725
Permanent ID: ys:prov:90725@1
SHA-256: 8c0143aed39af4587f74be344045dea05148fb8aa07057a16cc3a40e4bef9e4e

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Full text

(a) Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect. (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.