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e-CFR data is current as of November 30, 2020

Title 21Chapter ISubchapter HPart 882Subpart 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).

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