GXM · Anvil, Skull Plate
Neurology · 21 CFR 882.4030 · Class 1
Overview
| Product Code | GXM |
|---|---|
| Device Name | Anvil, Skull Plate |
| Regulation | 21 CFR 882.4030 |
| Device Class | Class 1 |
| Review Panel | Neurology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
