Mazor X System (Mazor X Stealth Edition)
FDA 510(k) clearance K230064 · decided 2023-04-07
Clearance details
- K-number
- K230064
- Device name
- Mazor X System (Mazor X Stealth Edition)
- Applicant
- Mazor Robotics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-01-09
- Decision date
- 2023-04-07
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- OLO
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Caesarea Business Park, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Mazor X robotic guidance system REF: TPL0059 recall (Z-1122-2026) | Mazor Robotics Ltd | 2026-01-16 |
| Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument recall (Z-3156-2024) | Mazor Robotics Ltd | 2024-09-16 |