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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K230064

Mazor X System (Mazor X Stealth Edition) · Mazor Robotics , Ltd. · decided 2023-04-07 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Scalpel HandleMAS2240-07SMAZOR ROBOTICS LTDLLZ OLO07290115752724
Schanz Screw 4x80mmMAS3010-03MAZOR ROBOTICS LTDLLZ OLO07290115752427
Long CannulaMAS2241-07SMAZOR ROBOTICS LTDLLZ OLO07290115752632
Schanz BridgeMAS2856-03MAZOR ROBOTICS LTDLLZ OLO07290115752267
Mazor X Guidewire Instruments SetKIT0854-04MAZOR ROBOTICS LTDLLZ OLO07290115751437
Long drill 3x80mm,10 packKIT0738-07MAZOR ROBOTICS LTDLLZ OLO07290115752830
10.5 Arm Guide Screw KitKIT1488-02MAZOR ROBOTICS LTDLLZ OLO07290115752458
Long Drill 3.0x30MAS2260-05SMAZOR ROBOTICS LTDLLZ OLO07290115752687
Snapshot Tracker KitKIT0898-06MAZOR ROBOTICS LTDLLZ OLO07290115751352
Long Drill 4x80mm, 10 packKIT0735-07MAZOR ROBOTICS LTDLLZ OLO07290115752823
BranchMAS2637-04MAZOR ROBOTICS LTDLLZ OLO07290115752335
Bridge AdaptorMAS2382-04MAZOR ROBOTICS LTDLLZ OLO07290115752236
Mazor X Scan & Plan Disposable KitKIT0571-11MAZOR ROBOTICS LTDLLZ OLO07290115753462
Short Drill Guide MAS2245-07SMAZOR ROBOTICS LTDLLZ OLO07290115752601
Mazor X Navigation CameraTPL0063-07MAZOR ROBOTICS LTDLLZ OLO07290115752755
Schanz Screw 4X150mm MAS2865-03MAZOR ROBOTICS LTDLLZ OLO07290115752380
Mazor X Spine Disposable KitKIT0574-13MAZOR ROBOTICS LTDLLZ OLO07290115753479
Bridge LockMAS2383-04MAZOR ROBOTICS LTDLLZ OLO07290115752243
Reference MarkerMAS1295-08SMAZOR ROBOTICS LTDLLZ OLO07290115752748
Radiolucent MIS ClampMAS2480-04MAZOR ROBOTICS LTDLLZ OLO07290115752304
4.75 Arm Guide Screw KitKIT0894-06MAZOR ROBOTICS LTDLLZ OLO07290115751314
Long Drill 3.0x80MAS2259-05SMAZOR ROBOTICS LTDLLZ OLO07290115752670
Short BranchMAS2643-04MAZOR ROBOTICS LTDLLZ OLO07290115752359
Head Pin 2.5x100mmMAS2868-03MAZOR ROBOTICS LTDLLZ OLO07290115752410
Short ClampMAS2609-04MAZOR ROBOTICS LTDLLZ OLO07290115752328