Rochester, MN, US · 2 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HAW | — | — | — | 2 | 2023-07-14 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-02-26 | Class II | Ongoing | Z-1478-2024 | NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 | — | Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereo… |