OXF · Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | OXF |
|---|---|
| Device Name | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification Rationale
Class II.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251224 | Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. | Jun 20, 2025 | SESE |
| K243302 | 3DMatrix DynaFlex (DynaFlex) | Printbio, Inc. | May 21, 2025 | SESE |
| K232602 | 3DMatrix Surgical Mesh | Printbio, Inc. | May 23, 2024 | SESE |
| K222919 | GORE® ENFORM Biomaterial | W. L. Gore and Associates, Inc. | Dec 19, 2022 | SESE |
| K173333 | GORE ENFORM Biomaterial | W. L. Gore & Associates, Inc. | Apr 5, 2018 | SESE |
| K172545 | SERI Contour | Sofregen Medical, Inc. | Sep 22, 2017 | SESE |
| K163217 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | Feb 10, 2017 | SESE |
| K123128 | SERI SURGICAL SCAFFOLD | Allergan | Apr 25, 2013 | SESE |
Top Applicants
- Printbio, Inc. — 2 clearances
- W. L. Gore & Associates, Inc. — 2 clearances
- Acera Surgical, Inc. — 1 clearance
- Allergan — 1 clearance
- Sofregen Medical, Inc. — 1 clearance
