OWR · Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | OWR |
|---|---|
| Device Name | Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201153 | Tisuthes e-PTFE Surgical Patch | Shanghai Suokang Medical Implants Co., Ltd. | Jun 13, 2023 | SESE |
Top Applicants
- Shanghai Suokang Medical Implants Co., Ltd. — 1 clearance
