EZX · Mesh, Surgical, Metal
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | EZX |
|---|---|
| Device Name | Mesh, Surgical, Metal |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification Rationale
Class II.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K063461 | ANOVA CONTAINMENT DEVICE | Anova Corporation | Aug 13, 2009 | SESE |
| K014200 | OPTIMESH | Spineology, Inc. | Nov 26, 2003 | SESU |
| K032344 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 | Implex Corp. | Oct 2, 2003 | SESE |
| K032282 | MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | Implex Corp. | Aug 21, 2003 | SESE |
| K024169 | MACROPORE OS RECONSTRUCTION | Macropore Biosurgery, Inc. | Jul 1, 2003 | SESE |
| K023882 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | Implex Corp. | Feb 19, 2003 | SESE |
| K020853 | NUVASIVE MESH | Nuvasive, Inc. | Jun 13, 2002 | SESE |
| K983766 | SYNTHES SYNMESH | Synthes (Usa) | Dec 18, 1998 | SESE |
| K945027 | TROCHANTER MESH | Acu Med, Inc. | Feb 1, 1995 | SN |
| K900138 | MOTECH TITANIUM SURGICAL MESH | Biedermann Motech GmbH | Mar 20, 1990 | SESE |
| K896369 | TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM | Techmedica, Inc. | Nov 24, 1989 | SESE |
| K890601 | STUART TITANIUM SURGICAL MESH | Stuart | Mar 16, 1989 | SESE |
Top Applicants
- Implex Corp. — 3 clearances
- Acu Med, Inc. — 1 clearance
- Anova Corporation — 1 clearance
- Biedermann Motech GmbH — 1 clearance
- Macropore Biosurgery, Inc. — 1 clearance
