OXF
- Product code
- OXF
- Device name
- Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 8
FDA classification definition
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251224 | 2025-06-20 | Acera Surgical, Inc. | Restrata Soft Tissue Reinforcement (STR) | |
| K243302 | 2025-05-21 | Printbio, Inc. | 3DMatrix DynaFlex (DynaFlex) | |
| K232602 | 2024-05-23 | Printbio, Inc. | 3DMatrix Surgical Mesh |
Official FDA classification page: OXF
Classification and pathway per current FDA publications. Data from openFDA (CC0).