Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4030](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4030) → GXM — Anvil, Skull Plate

# GXM · Anvil, Skull Plate

_Neurology · 21 CFR 882.4030 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXM

## Overview

- **Product Code:** GXM
- **Device Name:** Anvil, Skull Plate
- **Regulation:** [21 CFR 882.4030](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4030)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## 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._

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXM](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXM)

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