OXJ · Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | OXJ |
|---|---|
| Device Name | Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K161939 | Avance Abdominal Dressing Kit | Molnlycke Health Care Us, LLC | Nov 17, 2016 | SESE |
| K130852 | AVANCE® FOAM ABDOMINAL DRESSING KIT | Molnlycke Health Care | Apr 14, 2014 | SESE |
Top Applicants
- Molnlycke Health Care Us, LLC — 1 clearance
- Molnlycke Health Care — 1 clearance
