21 C.F.R. § 882.5300

Methyl methacrylate for cranioplasty.

Last amended: 2016Year: 2026Length: 56 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 882.5300 (2026)

(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).
21 C.F.R. § 882.5300: Methyl methacrylate for cranioplasty. | Justis AI