OXH · Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | OXH |
|---|---|
| Device Name | Mesh, Surgical, Collagen, 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251844 | Kerecis SurgiBind (50241) | Kerecis Limited | Jul 15, 2025 | SESE |
| K202430 | Kerecis Reconstruct | Kerecis Limited | May 2, 2021 | SESE |
| K171357 | SurgiMend PRS Meshed, Revize-X | Integra Lifesciences Corporation (Owner of Tei Biosciences) | Jun 7, 2017 | SESE |
| K160400 | Miromatrix Biological Mesh | Miromatrix Medical, Inc. | Jun 8, 2016 | SESE |
| K150341 | Miromatrix Biological Mesh RS | Miromatrix Medical, Inc. | May 12, 2015 | SESE |
Top Applicants
- Miromatrix Medical, Inc. — 2 clearances
- Kerecis Limited — 2 clearances
- Integra Lifesciences Corporation (Owner of Tei Biosciences) — 1 clearance
