FDA product code ODU: Facial Implant
ODU is the FDA product code for facial implant. It is a Class II device, regulated under 21 CFR 878.3500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under ODU. The average 510(k) review took 78 days (median 78).
Definition
For use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks.
Classification
| Field | Value |
|---|---|
| Device name | Facial Implant |
| Device class | Class II |
| Regulation | 21 CFR 878.3500 |
| 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 ODU clearance
Top ODU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgisil | 1 | 2007-09-19 |
Most recent ODU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K071823 | Surgisil | PERMA FACIAL IMPLANTS | 2007-09-19 | 78 |
Recalls for ODU devices
openFDA lists no recalls for product code ODU.
Frequently asked questions
What is FDA product code ODU?
ODU is the FDA product code for facial implant. It is a Class II device, regulated under 21 CFR 878.3500 and reviewed by the General and Plastic Surgery panel.
What device class is ODU?
Class II, regulation 21 CFR 878.3500. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODU?
Across 1 cleared submissions the average was 78 days from receipt to decision (median 78).
Which companies have the most ODU clearances?
Surgisil (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ODU
- Run a recall and safety report across every ODU manufacturer
- Watch product code ODU 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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