Eragny Sur Oise, FR · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 1 | 2020-07-30 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-06-03 | Class II | Completed | Z-1572-2022 | SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740. | — | The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct. |