Jacksonville, FL, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JEC | — | — | — | 1 | 2020-03-02 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-06-18 | Class II | Terminated | Z-2778-2020 | Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded… | — | High rate of galling of one threaded component. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2020-03-02 | K193256 | Anjon Bremer Halo System | JEC | — | — |