21 C.F.R. § 882.5300 Methyl methacrylate for cranioplasty.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart F—Neurological Therapeutic Devices
§ 882.5300 Methyl methacrylate for cranioplasty.
