Miami Device Solutions, LLC.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0603-2020 | Class II | Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating | January 15, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K182810 | Distal Radius Plating System | December 10, 2018 |
| K172786 | MDS Plating System | December 8, 2017 |
| K162898 | Olecranon Plating System | March 17, 2017 |
| K162635 | Distal Radius Plating System | October 21, 2016 |
| K161292 | Distal Radius Plating System | August 15, 2016 |
| K161058 | Cannulated Screw | July 29, 2016 |
| K141493 | PROXIMAL HUMERUS PLATING SYSTEM | March 20, 2015 |