| Device |
mesh, surgical, non-absorbable, orthopaedics, reinforcement of tendon |
| Regulation Description |
Surgical mesh. |
| Definition |
For reinforcement of soft tissue where weakness exists in tendon repair. |
| Physical State |
A non-absorbable mesh; either square, rectangular, round or of other various shapes. |
| Technical Method |
A non-absorbable mesh that reinforces soft tissue. |
| Target Area |
Tendon |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | OWX |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.3300
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
