Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4900](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4900) → GXL — Screwdriver, Skullplate

# GXL · Screwdriver, Skullplate

_Neurology · 21 CFR 882.4900 · Class 1_

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

## Overview

- **Product Code:** GXL
- **Device Name:** Screwdriver, Skullplate
- **Regulation:** [21 CFR 882.4900](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4900)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

A skullplate screwdriver is a tool used by the surgeon to fasten cranioplasty plates or skullplates to a patient's skull by screws.

## 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/GXL](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXL)

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