FDA product code FZD: Prosthesis, Ear, Internal
FZD is the FDA product code for prosthesis, ear, internal. It is a Class II device, regulated under 21 CFR 878.3590 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under FZD, from 3 different applicants. The average 510(k) review took 142 days (median 67).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Ear, Internal |
| Device class | Class II |
| Regulation | 21 CFR 878.3590 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for FZD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 344 |
Compare with all 510(k) review times · Search every FZD clearance
Top FZD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Implantech Associates, Inc. | 1 | 2018-07-18 |
| Porex Medical | 1 | 1986-10-24 |
| Richards Medical Co., Inc. | 1 | 1985-02-26 |
Most recent FZD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172389 | Implantech Associates, Inc. | ePTFE-Coated Auricular Implant | 2018-07-18 | 344 |
| K863939 | Porex Medical | POREX(TM) EAR PROSTHESIS | 1986-10-24 | 14 |
| K844960 | Richards Medical Co., Inc. | CANAL WALL PROSTHESIS | 1985-02-26 | 67 |
Recalls for FZD devices
openFDA lists no recalls for product code FZD.
Frequently asked questions
What is FDA product code FZD?
FZD is the FDA product code for prosthesis, ear, internal. It is a Class II device, regulated under 21 CFR 878.3590 and reviewed by the General and Plastic Surgery panel.
What device class is FZD?
Class II, regulation 21 CFR 878.3590. Typical premarket route: 510(k).
How long does a 510(k) take for product code FZD?
Across 3 cleared submissions the average was 142 days from receipt to decision (median 67).
Which companies have the most FZD clearances?
Implantech Associates, Inc. (1); Porex Medical (1); Richards Medical Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FZD
- Run a recall and safety report across every FZD manufacturer
- Watch product code FZD 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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