EZX — Mesh, Surgical, Metal Class II
FDA product code EZX covers "Mesh, Surgical, Metal", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EZX
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K063461 | anova corporation | ANOVA CONTAINMENT DEVICE | August 13, 2009 |
| K014200 | spineology | OPTIMESH | November 26, 2003 |
| K032344 | implex | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 | October 2, 2003 |
| K032282 | implex | MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | August 21, 2003 |
| K024169 | macropore biosurgery | MACROPORE OS RECONSTRUCTION | July 1, 2003 |
| K023882 | implex | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | February 19, 2003 |
| K020853 | nuvasive | NUVASIVE MESH | June 13, 2002 |
| K983766 | synthes (usa) | SYNTHES SYNMESH | December 18, 1998 |
| K945027 | acu med | TROCHANTER MESH | February 1, 1995 |
| K900138 | biedermann motech | MOTECH TITANIUM SURGICAL MESH | March 20, 1990 |
| K896369 | techmedica | TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM | November 24, 1989 |
| K890601 | stuart | STUART TITANIUM SURGICAL MESH | March 16, 1989 |