Product code EZX
- Device name
- Mesh, Surgical, Metal
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3300
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K063461 | ANOVA CONTAINMENT DEVICE | Anova Corporation | 2009-08-13 |
| K014200 | OPTIMESH | Spineology, Inc. | 2003-11-26 |
| K032344 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 | Implex Corp. | 2003-10-02 |
| K032282 | MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | Implex Corp. | 2003-08-21 |
| K024169 | MACROPORE OS RECONSTRUCTION | Macropore Biosurgery, Inc. | 2003-07-01 |
| K023882 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | Implex Corp. | 2003-02-19 |
| K020853 | NUVASIVE MESH | Nuvasive, Inc. | 2002-06-13 |
| K983766 | SYNTHES SYNMESH | Synthes (Usa) | 1998-12-18 |
| K945027 | TROCHANTER MESH | Acu Med, Inc. | 1995-02-01 |
| K900138 | MOTECH TITANIUM SURGICAL MESH | Biedermann Motech GmbH | 1990-03-20 |
| K896369 | TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM | Techmedica, Inc. | 1989-11-24 |
| K890601 | STUART TITANIUM SURGICAL MESH | Stuart | 1989-03-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10705034785295 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785431 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785424 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785417 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785400 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785394 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785387 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785370 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785363 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785356 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785349 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785332 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785325 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785318 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785301 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785141 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785288 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785271 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785264 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785257 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785240 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785233 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785226 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785219 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785202 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785196 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785189 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785172 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785165 | SynMesh | Synthes GmbH | 2015-09-14 |
| 10705034785158 | SynMesh | Synthes GmbH | 2015-09-14 |