Mesh, Surgical, Metal
FDA product code EZX · Class II (moderate risk) · 21 CFR 878.3300 · General, Plastic Surgery
12510(k) clearances
0PMA approvals
1recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K063461 | Anova Containment DeviceEZX · Traditional | Anova Corporation | 08/13/2009SE |
| K014200 | OptimeshEZX · Traditional | Spineology, Inc. | 11/26/2003SESU |
| K032344 | The Hedrocel Trabecular Metal Reconstruction System Model 10-330EZX · Special | Implex Corp. | 10/02/2003SE |
| K032282 | Modification to Hedrocel Trabecular Metal Reconstruction SystemEZX · Special | Implex Corp. | 08/21/2003SE |
| K024169 | Macropore Os ReconstructionEZX · Traditional | Macropore Biosurgery, Inc. | 07/01/2003SE |
| K023882 | The Hedrocel Trabecular Metal Reconstruction SystemEZX · Traditional | Implex Corp. | 02/19/2003SE |
| K020853 | Nuvasive MeshEZX · Traditional | Nuvasive, Inc. | 06/13/2002SE |
| K983766 | Synthes SynmeshEZX · Traditional | Synthes (Usa) | 12/18/1998SE |
| K945027 | Trochanter MeshEZX · Traditional | Acu Med, Inc. | 02/01/1995SN |
| K900138 | Motech Titanium Surgical MeshEZX · Traditional | Biedermann Motech GmbH | 03/20/1990SE |
| K896369 | Titanium Mesh Maxillofacial Implant SystemEZX · Traditional | Techmedica, Inc. | 11/24/1989SE |
| K890601 | Stuart Titanium Surgical MeshEZX · Traditional | Stuart | 03/16/1989SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0192-2016 Class II | Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The…The affected part number and lot listed above is incorrectly etched with the wrong part number and may not… | Synthes (USA) Products LLC | 10/07/2015Terminated |