Scorecard
Events per device across the 47-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0 →
0 in the last 12 months
Higher volume than 83% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
47 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|
| 3.5 mm Hex Head Screwdriver | A40043 | OLO | 03701311500735 | 1 |
| 3D Offset Imaging Set SPX1 | A01038 | JAA OWB OXO | 03701311500971 | 1 |
| 3D Offset Imaging Set SPX1 | A00038 | JAA OWB OXO | 03701311500391 | 1 |
| Broach Set SPX1 | A00021 | JAA OWB OXO | 03701311500032 | 1 |
| CoBot | I00019 | OLO | 03701311500322 | 1 |
| CoBot, Drill Bit | A40041 | OLO | 03701311500704 | 1 |
| CoBot, Drill Guide – Cortical tip | A40042 | OLO | 03701311500728 | 1 |
| CoBot, Drill Guide – Sleeve | A40046 | OLO | 03701311500711 | 1 |
| CoBot, Spine Instruments tray | A40045 | OLO | 03701311500766 | 1 |
| CoBot, Tool Holder | A40044 | OLO | 03701311500759 | 1 |
| Fixation screw | A40047 | OLO | 03701311500742 | 1 |
| Robotic, Tool Holder – Tracker | A40059 | OLO | 03701311500773 | 1 |
| 3D Imaging Set SPX1 | A01018 | JAA OWB OXO | 03701311500940 | 0 |
| 3D Imaging Set SPX1 | A00018 | JAA OWB OXO | 03701311500018 | 0 |
| Broach Set SPX1 | A01021 | JAA OWB OXO | 03701311500995 | 0 |
| Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125mm | A00020 | OLO | 03701311500056 | 0 |
| Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125mm | A01020 | OLO | 03701311501015 | 0 |
| Navigated Targeting Needle SPX1, Trocar tip – 11G, 125 mm | A01028 | OLO | 03701311501039 | 0 |
| Navigated Targeting Needle SPX1, Trocar Tip – 11G, 125mm | A00028 | OLO | 03701311500414 | 0 |
| Navigation Instrument tray | A00067 | OLO | 03701311500902 | 0 |
| Navigation Set SPX1, Targeting Needle Bevel Tip - 11G, 125mm | A00019 | OLO | 03701311500070 | 0 |
| Navigation Set SPX1, Targeting Needle Trocar Tip – 11G, 125mm | A00029 | OLO | 03701311500421 | 0 |
| Navigation set SPX1, Targeting Needle SPX1, Bevel Tip - 11G, 125 mm | A01019 | OLO | 03701311501053 | 0 |
| Navigation set SPX1, Targeting Needle SPX1, Trocar Tip - 11G, 125 mm | A01029 | OLO | 03701311501077 | 0 |
| Op.n Camera | I00026 | OLO | 03701311501275 | 0 |
| Op.n ChoiceSpine App | L60018 | OLO | 03701311501497 | 0 |
| Op.n Core | I01014 | OLO | 03701311501435 | 0 |
| Op.n Core HDMI cable | I01018 | OLO | 03701311501466 | 0 |
| Op.n Core Power Cord | I01015 | OLO | 03701311501442 | 0 |
| Op.n Core ethernet cable | I01016 | OLO | 03701311501459 | 0 |
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|
| 3021060474 | ECENTIAL ROBOTICS | Gieres Isere, FR | VAI | |