Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5300](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5300) → MYU — Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty

# MYU · Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty

_Neurology · 21 CFR 882.5300 · Class 2_

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

## Overview

- **Product Code:** MYU
- **Device Name:** Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
- **Regulation:** [21 CFR 882.5300](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5300)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **Implant:** yes

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K033230](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MYU/K033230.md) | TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA | Parallax Medical, Inc. | Dec 12, 2003 | SESE |
| [K032388](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MYU/K032388.md) | BONE CEMENT RADIO-OPACIFIER | Cardinalhealth | Oct 31, 2003 | SESE |
| [K024359](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MYU/K024359.md) | VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 | Vista Scientific, LLC | Aug 8, 2003 | SESE |
| [K023445](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MYU/K023445.md) | TRACERS BONE CEMENT OPACIFIER | Parallax Medical, Inc. | Mar 11, 2003 | SESE |
| [K002063](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MYU/K002063.md) | BIOTRACE, MODEL 1730 | Bryan Corp. | Aug 10, 2000 | SESE |
| [K991893](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MYU/K991893.md) | PARALLAX TRACER RADIOPAQUE PARTICLES | Parallax Medical, Inc. | Aug 13, 1999 | SESE |

## Top Applicants

- Parallax Medical, Inc. — 3 clearances
- Bryan Corp. — 1 clearance
- Cardinalhealth — 1 clearance
- Vista Scientific, LLC — 1 clearance

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

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