FDA product code NEA: Cement, Ear, Nose And Throat
NEA is the FDA product code for cement, ear, nose and throat. It is a Class II device, regulated under 21 CFR 872.3275 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 6 510(k) submissions under NEA, from 6 different applicants. The average 510(k) review took 75 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Cement, Ear, Nose And Throat |
| Device class | Class II |
| Regulation | 21 CFR 872.3275 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NEA clearance
Top NEA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ototronix, LLC | 1 | 2014-06-19 |
| Envoy Medical Corporation | 1 | 2008-02-28 |
| Stryker Cmf | 1 | 2006-04-19 |
| Walter Lorenz Surgical, Inc. | 1 | 2004-11-08 |
| Ototech, Inc. | 1 | 2001-09-13 |
1 more applicants have NEA clearances. See the full list in Caduvo.
Most recent NEA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140644 | Ototronix, LLC | PROCEM | 2014-06-19 | 98 |
| K080032 | Envoy Medical Corporation | ENVOYCEM, MODEL 1640 | 2008-02-28 | 52 |
| K060750 | Stryker Cmf | STRYKER INJECTABLE CEMENT | 2006-04-19 | 29 |
| K042516 | Walter Lorenz Surgical, Inc. | OTOMIMIX | 2004-11-08 | 53 |
| K011338 | Ototech, Inc. | OTO-CEM | 2001-09-13 | 134 |
Recalls for NEA devices
openFDA lists no recalls for product code NEA.
Frequently asked questions
What is FDA product code NEA?
NEA is the FDA product code for cement, ear, nose and throat. It is a Class II device, regulated under 21 CFR 872.3275 and reviewed by the Ear, Nose and Throat panel.
What device class is NEA?
Class II, regulation 21 CFR 872.3275. Typical premarket route: 510(k).
How long does a 510(k) take for product code NEA?
Across 6 cleared submissions the average was 75 days from receipt to decision (median 68).
Which companies have the most NEA clearances?
Ototronix, LLC (1); Envoy Medical Corporation (1); Stryker Cmf (1); Walter Lorenz Surgical, Inc. (1); Ototech, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NEA
- Run a recall and safety report across every NEA manufacturer
- Watch product code NEA 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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