21 CFR 882.5300 — Methyl Methacrylate For Cranioplasty
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5300
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXP | Methyl Methacrylate For Cranioplasty | 2 | 43 | Implant |
| MYU | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty | 2 | 6 | Implant |
