21 CFR 882.4030 — Anvil, Skull Plate
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4030
Identification
A skull plate anvil is a device used to form alterable skull plates in the proper shape to fit the curvature of a patient's skull.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXM | Anvil, Skull Plate | 1 | 0 |
