Fx Solutions
Medical device manufacturer in Viriat, Rhone-Alpe, Fran.
8510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K163669 | Humeris ShoulderPHX · Traditional | 05/17/2017SE |
| K162455 | Humelock Reversed ShoulderPHX · Traditional | 01/17/2017SE |
| K150488 | Humelock II Reversible Shoulder SystemPHX · Traditional | 11/13/2015SE |
| K143721 | PRCT2HRS · Traditional | 08/27/2015SE |
| K140071 | Humelock II Cemented Shoulder SystemKWT · Traditional | 07/28/2014SE |
| K130759 | Humelock II Cementless Shoulder SystemHSD · Traditional | 11/09/2013SE |
| K123814 | Humelock II Cemented Shoulder SystemKWT · Traditional | 08/13/2013SE |
| K111097 | Humelock Cemented Shoulder ProsthesisHSD · Traditional | 11/09/2011SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2469-2018 Class II | Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to…Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. | 06/04/2018Terminated |
| Z-2468-2018 Class II | Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to…Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. | 06/04/2018Terminated |