ODUClass II
Facial Implant
21 CFR 878.3500 / General, Plastic Surgery
ODU is the FDA product code for Facial Implant, a class II device type, regulated under 21 CFR 878.3500. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- ODU
- Device name
- Facial Implant
- FDA 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.
- Regulation
- 21 CFR 878.3500
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code ODU
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2007 | 1 |
Applicants with the most clearances
Product code ODU| Applicant | Clearances |
|---|---|
| Surgisil | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code ODU.
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