FDA product code FZE: Prosthesis, Nose, Internal
FZE is the FDA product code for prosthesis, nose, internal. It is a Class II device, regulated under 21 CFR 878.3680 and reviewed by the General and Plastic Surgery panel. FDA has cleared 42 510(k) submissions under FZE, 1 in the last five years, from 25 different applicants. The average 510(k) review took 83 days (median 64); 223 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Nose, Internal |
| Device class | Class II |
| Regulation | 21 CFR 878.3680 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for FZE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 223 |
Compare with all 510(k) review times · Search every FZE clearance
Top FZE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Implantech Associates, Inc. | 7 | 1996-10-03 |
| Spirit Ridge Technologies | 5 | 1995-08-28 |
| Hanson Medical, Inc. | 4 | 2010-06-30 |
| Byron Medical | 3 | 1986-09-17 |
| Surgical Technology Laboratories, Inc. | 2 | 1998-11-20 |
20 more applicants have FZE clearances. See the full list in Caduvo.
Most recent FZE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241253 | Cmf Medicon Surgical, Inc. | Medicon Epiplating System | 2024-12-12 | 223 |
| K161548 | Southern Implants (Pty), Ltd. | Osseointegrated Fixtures | 2016-12-01 | 181 |
| K090803 | Hanson Medical, Inc. | HANSON MEDICAL FACIAL IMPLANTS | 2010-06-30 | 463 |
| K090630 | Nobel Biocare AB | NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) | 2009-06-02 | 85 |
| K071018 | Hanson Medical, Inc. | MONARCH NASAL IMPLANT | 2007-05-25 | 45 |
Recalls for FZE devices
openFDA lists no recalls for product code FZE.
Frequently asked questions
What is FDA product code FZE?
FZE is the FDA product code for prosthesis, nose, internal. It is a Class II device, regulated under 21 CFR 878.3680 and reviewed by the General and Plastic Surgery panel.
What device class is FZE?
Class II, regulation 21 CFR 878.3680. Typical premarket route: 510(k).
How long does a 510(k) take for product code FZE?
Across 42 cleared submissions the average was 83 days from receipt to decision (median 64).
Which companies have the most FZE clearances?
Implantech Associates, Inc. (7); Spirit Ridge Technologies (5); Hanson Medical, Inc. (4); Byron Medical (3); Surgical Technology Laboratories, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code FZE
- Run a recall and safety report across every FZE manufacturer
- Watch product code FZE 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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