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e-CFR data is current as of February 26, 2021 |
Title 21 → Chapter I → Subchapter H → Part 882 → Subpart F → §882.5300 |
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart F—Neurological Therapeutic Devices
§882.5300 Methyl methacrylate for cranioplasty.
(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).