← Product Code [GXR](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR) · K001096

# BURR HOLE COVER, MODEL XX (K001096)

_Image-Guided Neurologics, Inc. · GXR · Oct 25, 2000 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K001096

## Device Facts

- **Applicant:** Image-Guided Neurologics, Inc.
- **Product Code:** [GXR](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR.md)
- **Decision Date:** Oct 25, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.5250
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K001096](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K001096)

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