← Product Code [GXR](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR) · K002334

# MACROPORENS CRANILOC (K002334)

_Macropore Biosurgery, Inc. · GXR · May 2, 2001 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K002334

## Device Facts

- **Applicant:** Macropore Biosurgery, Inc.
- **Product Code:** [GXR](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR.md)
- **Decision Date:** May 2, 2001
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K002334](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXR/K002334)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com