EZX
12 FDA 510(k) clearances · Product code
90 daysmedian time to decision
705 days90th percentile
12clearances measured
FDA profile
- Official device name
- Mesh, Surgical, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- Adverse events (MAUDE)
- 2014: 7 · 2015: 9 · 2018: 11 · 2019: 29 · 2020: 25 · 2021: 35
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ANOVA CONTAINMENT DEVICE (K063461) | Anova Corporation | 2009-08-13 |
| OPTIMESH (K014200) | Spineology, Inc. | 2003-11-26 |
| THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 (K032344) | Implex Corp. | 2003-10-02 |
| MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM (K032282) | Implex Corp. | 2003-08-21 |
| MACROPORE OS RECONSTRUCTION (K024169) | Macropore Biosurgery, Inc. | 2003-07-01 |
| THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM (K023882) | Implex Corp. | 2003-02-19 |
| NUVASIVE MESH (K020853) | Nuvasive, Inc. | 2002-06-13 |
| SYNTHES SYNMESH (K983766) | Synthes (Usa) | 1998-12-18 |
| TROCHANTER MESH (K945027) | Acu Med, Inc. | 1995-02-01 |
| MOTECH TITANIUM SURGICAL MESH (K900138) | Biedermann Motech GmbH | 1990-03-20 |
| TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM (K896369) | Techmedica, Inc. | 1989-11-24 |
| STUART TITANIUM SURGICAL MESH (K890601) | Stuart | 1989-03-16 |
Track EZX automatically
Every clearance here is in the API, with alerts when new ones post.