TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
Device Facts
| Record ID | K010528 |
|---|---|
| Device Name | TITANIUM CEMENT RESTRICTOR MATERIAL PEEK |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Product Code | JDK · General, Plastic Surgery |
| Decision Date | Oct 10, 2001 |
| Decision | SESU |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
Regulatory Classification
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.
