← Product Code [GXP](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP) · K011399

# BIOMET CRANIOFACIAL ACRYLIC CEMENT (K011399)

_Biomet, Inc. · GXP · May 5, 2003 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K011399

## Device Facts

- **Applicant:** Biomet, Inc.
- **Product Code:** [GXP](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP.md)
- **Decision Date:** May 5, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.5300
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K011399](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K011399)

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