Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K251316
Mazor X System / Mazor X Stealth Edition · Mazor Robotics , Ltd. · decided 2025-09-11 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Scalpel Handle | MAS2240-07S | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752724 |
| Schanz Screw 4x80mm | MAS3010-03 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752427 |
| Long Cannula | MAS2241-07S | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752632 |
| Schanz Bridge | MAS2856-03 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752267 |
| Mazor X Guidewire Instruments Set | KIT0854-04 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115751437 |
| Long drill 3x80mm,10 pack | KIT0738-07 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752830 |
| 10.5 Arm Guide Screw Kit | KIT1488-02 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752458 |
| Long Drill 3.0x30 | MAS2260-05S | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752687 |
| Snapshot Tracker Kit | KIT0898-06 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115751352 |
| Long Drill 4x80mm, 10 pack | KIT0735-07 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752823 |
| Branch | MAS2637-04 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752335 |
| Bridge Adaptor | MAS2382-04 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752236 |
| Mazor X Scan & Plan Disposable Kit | KIT0571-11 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115753462 |
| Short Drill Guide | MAS2245-07S | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752601 |
| Mazor X Navigation Camera | TPL0063-07 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752755 |
| Schanz Screw 4X150mm | MAS2865-03 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752380 |
| Mazor X Spine Disposable Kit | KIT0574-13 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115753479 |
| Bridge Lock | MAS2383-04 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752243 |
| Reference Marker | MAS1295-08S | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752748 |
| Radiolucent MIS Clamp | MAS2480-04 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752304 |
| 4.75 Arm Guide Screw Kit | KIT0894-06 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115751314 |
| Long Drill 3.0x80 | MAS2259-05S | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752670 |
| Short Branch | MAS2643-04 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752359 |
| Head Pin 2.5x100mm | MAS2868-03 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752410 |
| Short Clamp | MAS2609-04 | MAZOR ROBOTICS LTD | LLZ OLO | 07290115752328 |