FDA product code EZX: Mesh, Surgical, Metal
EZX is the FDA product code for mesh, surgical, metal. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 12 510(k) submissions under EZX, from 10 different applicants. The average 510(k) review took 205 days (median 79). FDA has posted 1 recall for EZX devices.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Metal |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every EZX clearance
Top EZX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Implex Corp. | 3 | 2003-10-02 |
| Anova Corporation | 1 | 2009-08-13 |
| Spineology, Inc. | 1 | 2003-11-26 |
| Macropore Biosurgery, Inc. | 1 | 2003-07-01 |
| Nuvasive, Inc. | 1 | 2002-06-13 |
5 more applicants have EZX clearances. See the full list in Caduvo.
Most recent EZX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K063461 | Anova Corporation | ANOVA CONTAINMENT DEVICE | 2009-08-13 | 1002 |
| K014200 | Spineology, Inc. | OPTIMESH | 2003-11-26 | 705 |
| K032344 | Implex Corp. | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 | 2003-10-02 | 64 |
| K032282 | Implex Corp. | MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | 2003-08-21 | 28 |
| K024169 | Macropore Biosurgery, Inc. | MACROPORE OS RECONSTRUCTION | 2003-07-01 | 195 |
Recalls for EZX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-10-07.
Frequently asked questions
What is FDA product code EZX?
EZX is the FDA product code for mesh, surgical, metal. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel.
What device class is EZX?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code EZX?
Across 12 cleared submissions the average was 205 days from receipt to decision (median 79).
Which companies have the most EZX clearances?
Implex Corp. (3); Anova Corporation (1); Spineology, Inc. (1); Macropore Biosurgery, Inc. (1); Nuvasive, Inc. (1).
Have EZX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-10-07.
Next steps
- Run an FDA pathway report with predicate devices for product code EZX
- Run a recall and safety report across every EZX manufacturer
- Watch product code EZX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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