Methyl methacrylate for cranioplasty.

21 C.F.R. § 882.5300
in effectEffective: 2024-07-01
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(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).

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