Signal Medical Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 2
- Inspections
- 10
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1834-2017 | Class II | Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090 | February 20, 2017 |
| Z-0111-2015 | Class II | Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is | September 30, 2014 |
| Z-0109-2015 | Class II | Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM | September 23, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K203779 | Symmetric Total Knee System | June 10, 2021 |
| K080199 | SYMMETRIC TOTAL KNEE SYSTEM | July 3, 2008 |