FDA Product Code
FDA Product Code OXF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251224 | Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. | 2025-06-20 | Traditional | PDF ↗ |
| K243302 | 3DMatrix DynaFlex (DynaFlex) | Printbio, Inc. | 2025-05-21 | Traditional | PDF ↗ |
| K232602 | 3DMatrix Surgical Mesh | Printbio, Inc. | 2024-05-23 | Traditional | PDF ↗ |
| K222919 | GORE® ENFORM Biomaterial | W. L. Gore and Associates, Inc. | 2022-12-19 | Traditional | PDF ↗ |
| K173333 | GORE ENFORM Biomaterial | W. L. Gore & Associates, Inc. | 2018-04-05 | Traditional | PDF ↗ |
| K172545 | SERI Contour | Sofregen Medical, Inc. | 2017-09-22 | Special | PDF ↗ |
| K163217 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017-02-10 | Traditional | PDF ↗ |
| K123128 | SERI SURGICAL SCAFFOLD | Allergan | 2013-04-25 | Traditional | PDF ↗ |
Product code OXF · Class II · General, Plastic Surgery. Data: openFDA.