MYU · Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
Neurology · 21 CFR 882.5300 · Class 2
Overview
| Product Code | MYU |
|---|---|
| Device Name | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty |
| Regulation | 21 CFR 882.5300 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA | Parallax Medical, Inc. | Dec 12, 2003 | SESE |
| K032388 | BONE CEMENT RADIO-OPACIFIER | Cardinalhealth | Oct 31, 2003 | SESE |
| K024359 | VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 | Vista Scientific, LLC | Aug 8, 2003 | SESE |
| K023445 | TRACERS BONE CEMENT OPACIFIER | Parallax Medical, Inc. | Mar 11, 2003 | SESE |
| K002063 | BIOTRACE, MODEL 1730 | Bryan Corp. | Aug 10, 2000 | SESE |
| K991893 | 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
