MYU — Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty Class II
FDA product code MYU covers "Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty", a Class II medical device regulated under 21 CFR 882.5300. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MYU
- Device Class
- Class II
- Regulation Number
- 882.5300
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K033230 | parallax medical | TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA | December 12, 2003 |
| K032388 | cardinalhealth | BONE CEMENT RADIO-OPACIFIER | October 31, 2003 |
| K024359 | vista scientific | VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 | August 8, 2003 |
| K023445 | parallax medical | TRACERS BONE CEMENT OPACIFIER | March 11, 2003 |
| K002063 | bryan | BIOTRACE, MODEL 1730 | August 10, 2000 |
| K991893 | parallax medical | PARALLAX TRACER RADIOPAQUE PARTICLES | August 13, 1999 |