Panels › General, Plastic Surgery › Product code EZX · Class 2
Mesh, Surgical, Metal
Regulation 878.3300
0510(k)s in 12 months (12 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in EZX
| Company | 510(k)s | Recalls |
|---|---|---|
| Implex Corp. | 3 | 0 |
| Acu Med, Inc. | 1 | 0 |
| Anova Corporation | 1 | 0 |
| Biedermann Motech GmbH | 1 | 0 |
| Macropore Biosurgery, Inc. | 1 | 0 |
| Nuvasive, Inc. | 1 | 0 |
| Spineology, Inc. | 1 | 0 |
| Stuart | 1 | 0 |
| Synthes (Usa) | 1 | 0 |
| Synthes (USA) Products LLC | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2009 | K063461 | ANOVA CONTAINMENT DEVICE Anova Corporation | EZX |
| Nov 26, 2003 | K014200 | OPTIMESH Spineology, Inc. | EZX |
| Oct 2, 2003 | K032344 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 Implex Corp. | EZX |
| Aug 21, 2003 | K032282 | MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM Implex Corp. | EZX |
| Jul 1, 2003 | K024169 | MACROPORE OS RECONSTRUCTION Macropore Biosurgery, Inc. | EZX |
| Feb 19, 2003 | K023882 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM Implex Corp. | EZX |
| Jun 13, 2002 | K020853 | NUVASIVE MESH Nuvasive, Inc. | EZX |
| Dec 18, 1998 | K983766 | SYNTHES SYNMESH Synthes (Usa) | EZX |
| Feb 1, 1995 | K945027 | TROCHANTER MESH Acu Med, Inc. | EZX |
| Mar 20, 1990 | K900138 | MOTECH TITANIUM SURGICAL MESH Biedermann Motech GmbH | EZX |
| Nov 24, 1989 | K896369 | TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM Techmedica, Inc. | EZX |
| Mar 16, 1989 | K890601 | STUART TITANIUM SURGICAL MESH Stuart | EZX |
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