Panels › General, Plastic Surgery › Product code OXF · Class 2
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Regulation 878.3300
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OXF
| Company | 510(k)s | Recalls |
|---|---|---|
| Printbio, Inc. | 2 | 0 |
| W. L. Gore & Associates, Inc. | 2 | 0 |
| Acera Surgical, Inc. | 1 | 0 |
| Allergan | 1 | 0 |
| Sofregen Medical, Inc. | 1 | 0 |
| W. L. Gore and Associates, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2025 | K251224 | Restrata Soft Tissue Reinforcement (STR) Acera Surgical, Inc. | OXF |
| May 21, 2025 | K243302 | 3DMatrix DynaFlex (DynaFlex) Printbio, Inc. | OXF |
| May 23, 2024 | K232602 | 3DMatrix Surgical Mesh Printbio, Inc. | OXF |
| Dec 19, 2022 | K222919 | GORE® ENFORM Biomaterial W. L. Gore and Associates, Inc. | OXF |
| Apr 5, 2018 | K173333 | GORE ENFORM Biomaterial W. L. Gore & Associates, Inc. | OXF |
| Sep 22, 2017 | K172545 | SERI Contour Sofregen Medical, Inc. | OXF |
| Feb 10, 2017 | K163217 | GORE BIO-A Tissue Reinforcement W. L. Gore & Associates, Inc. | OXF |
| Apr 25, 2013 | K123128 | SERI SURGICAL SCAFFOLD Allergan | OXF |
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