Mazor X System (Mazor X Stealth Edition)— 510(k) K230064
Substantially EquivalentMazor Robotics , Ltd.
FDA 510(k) clearance K230064 for Mazor X System (Mazor X Stealth Edition), Substantially Equivalent on 2023-04-07. Applicant: Mazor Robotics , Ltd.. Device class: 2.
Clearance details
- Applicant
- Mazor Robotics , Ltd.
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Caesarea Business Park, IL
Recent devices under product code OLO
view allMore clearances from Mazor Robotics , Ltd.
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K230064
K-number listed on FDA's recall record- Z-1122-2026 — Mazor X robotic guidance system REF: TPL0059
- Z-3156-2024 — Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K230064.
Data sourced from openFDA. This site is unofficial and independent of the FDA.