OXF
8 FDA 510(k) clearances · Product code
164 daysmedian time to decision
269 days90th percentile
8clearances measured
FDA profile
- Official device name
- Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
- Adverse events (MAUDE)
- 2013: 14 · 2014: 129 · 2015: 107 · 2016: 52 · 2017: 25
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Restrata Soft Tissue Reinforcement (STR) (K251224) | Acera Surgical, Inc. | 2025-06-20 |
| 3DMatrix DynaFlex (DynaFlex) (K243302) | Printbio, Inc. | 2025-05-21 |
| 3DMatrix Surgical Mesh (K232602) | Printbio, Inc. | 2024-05-23 |
| GORE® ENFORM Biomaterial (K222919) | W. L. Gore and Associates, Inc. | 2022-12-19 |
| GORE ENFORM Biomaterial (K173333) | W. L. Gore & Associates, Inc. | 2018-04-05 |
| SERI Contour (K172545) | Sofregen Medical, Inc. | 2017-09-22 |
| GORE BIO-A Tissue Reinforcement (K163217) | W. L. Gore & Associates, Inc. | 2017-02-10 |
| SERI SURGICAL SCAFFOLD (K123128) | Allergan | 2013-04-25 |
Track OXF automatically
Every clearance here is in the API, with alerts when new ones post.