Gieres, FR · 5 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 5 | 2024-01-26 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-08-30 | Class II | Ongoing | Z-0209-2025 | Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individua… | — | Predict+ is being recalled for lack of pre-market clearance/approval. |
| 2020-09-10 | Class II | Terminated | Z-0288-2021 | Instructions For Use document of the GPS Trackers. | — | Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-01-26 | K233299 | ExactechGPS® System | OLO | Class II | Neurology |
| 2023-11-16 | K232521 | ExactechGPS® Total Ankle Application | OLO | Class II | Neurology |
| 2022-05-02 | K213877 | ExactechGPS® System | OLO | Class II | Neurology |
| 2022-01-06 | K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | OLO | Class II | Neurology |
| 2020-09-02 | K193618 | ExactechGPS System | OLO | Class II | Neurology |