Mazor X System (Mazor X Stealth Edition)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230064 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Mazor X System (Mazor X Stealth Edition) is a robotic-assisted surgical guidance system classified under the product code OLO, designed for spinal and neurosurgical procedures. It integrates advanced navigation and robotic technologies to enhance precision during operative planning and execution, supporting procedures within neurology and orthopaedic surgery.
This system is supplied as a reusable medical device and is authorised under FDA 510(k) clearance (K230064) and the EU Medical Device Regulation (MDR). It is intended for use in sterile surgical environments, with no specific MRI safety classification noted in the available data. The device requires appropriate training and adherence to manufacturer guidelines for operation and maintenance.
Frequently asked questions
What types of surgical procedures is the Mazor X System (Mazor X Stealth Edition) primarily used for?
The Mazor X System (Mazor X Stealth Edition) is designed for robotic-assisted guidance in spinal and neurosurgical procedures. It integrates navigation and robotic technologies to improve precision during operative planning and execution, supporting both neurology and orthopaedic surgeries within these specialties.
Is the Mazor X System reusable or single-use, and how should it be handled in a sterile environment?
The Mazor X System is a reusable medical device, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. Since it is designed for sterile surgical environments, it must be handled according to manufacturer guidelines to ensure sterility and functionality before each procedure.
What regulatory pathways has the Mazor X System (Mazor X Stealth Edition) followed for approval?
The Mazor X System (Mazor X Stealth Edition) has been authorized through the FDA’s 510(k) clearance process (K230064) and complies with the EU Medical Device Regulation (MDR). These pathways confirm its substantial equivalence to a predicate device and adherence to regulatory standards for robotic-assisted surgical guidance systems.
Are there different models or sizes available for the Mazor X System, and if so, how would I determine which one is appropriate?
The provided data does not specify distinct models or sizes for the Mazor X System (Mazor X Stealth Edition). However, the system is designed for flexibility in spinal and neurosurgical procedures, so compatibility would depend on the specific clinical workflow and procedural requirements. Consulting the manufacturer’s documentation or a trained representative would help determine the best fit for your needs.
Does the Mazor X System have any special storage requirements or considerations?
While the data does not detail specific storage conditions, as a reusable medical device intended for sterile surgical use, the Mazor X System should be stored in a clean, controlled environment to prevent contamination or damage. Follow the manufacturer’s instructions for maintenance, calibration, and storage to ensure optimal performance and longevity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Mazor Robotic Guidance System | Medtronic, Mazor X Stealth Edition Robotic Guidance System - SPINEMarketGroup, Mazor™ Robotic Guidance System | Medtronic, Mazor X System / Mazor X Stealth Edition (K251316) — FDA 510 (k ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230064 | Class II | Active |
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Manufacturer
- Manufacturer
- Mazor Robotics Ltd
- FDA Applicant
- Mazor Robotics , Ltd.
Sources (2)
- FDA 510(k) K230064 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026