Company ยท FR
Fx Solutions
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2017. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 17, 2017 | K163669 | Humeris Shoulder Fx Solutions, FR | PHX |
| Jan 17, 2017 | K162455 | Humelock Reversed Shoulder Fx Solutions, FR | PHX |
| Nov 13, 2015 | K150488 | Humelock II Reversible Shoulder System Fx Solutions, FR | PHX |
| Aug 27, 2015 | K143721 | PRCT2 Fx Solutions, FR | HRS |
| Jul 28, 2014 | K140071 | HUMELOCK II CEMENTED SHOULDER SYSTEM Fx Solutions, FR | KWT |
| Nov 9, 2013 | K130759 | HUMELOCK II CEMENTLESS SHOULDER SYSTEM Fx Solutions, FR | HSD |
| Aug 13, 2013 | K123814 | HUMELOCK II CEMENTED SHOULDER SYSTEM Fx Solutions, FR | KWT |
| Nov 9, 2011 | K111097 | HUMELOCK CEMENTED SHOULDER PROSTHESIS Fx Solutions, FR | HSD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2018 | Fx Solutions Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000
Product Usage:
Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions suscept Terminated |
HSD | K111097 |
| Jun 4, 2018 | Fx Solutions Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019
Product Usage:
Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susce Terminated |
HSD | K111097 |