Mazor X System (Mazor X Stealth Edition)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182077 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 guidance system classified under the product code OLO, designed for spinal and neurosurgical procedures. It integrates advanced robotic technologies with navigation software to assist in precise surgical planning and execution, enhancing procedural accuracy and efficiency in orthopaedic and neurological interventions.
This system is supplied as a reusable medical device and is intended for use in sterile operating room environments. It is authorised under FDA 510(k) clearance (K182077) and meets the requirements of the EU Medical Device Regulation (MDR). The device is regulated under the Neurology advisory committee classification and is intended for use in spinal and brain surgeries, though its specific clinical indications are not stated in the regulatory data.
Frequently asked questions
What types of surgical procedures is the Mazor X System designed to assist with, and how does it improve accuracy in those procedures?
The Mazor X System (Mazor X Stealth Edition) is specifically designed to assist in spinal and neurosurgical procedures, including orthopaedic and neurological interventions like spinal and brain surgeries. It integrates robotic guidance with navigation software to enhance procedural accuracy and efficiency, reducing human error and improving precision during critical interventions. The system’s advanced technology helps surgeons plan and execute surgeries with greater control, particularly in complex cases where alignment and placement are critical.
Is the Mazor X System reusable, and if so, what considerations should be taken into account for its use in sterile operating room environments?
Yes, the Mazor X System is supplied as a reusable medical device, meaning it is intended for multiple uses across different procedures. Since it is designed for sterile operating room environments, proper sterilization protocols must be followed between uses to maintain hygiene and prevent contamination. The system’s reusable nature also implies that facilities must have dedicated cleaning, disinfection, and maintenance procedures in place to ensure reliability and compliance with surgical standards.
What regulatory pathways has the Mazor X System undergone, and how does this affect its availability in different markets?
The Mazor X System has undergone FDA 510(k) clearance (K182077) under the Traditional pathway, demonstrating substantial equivalence to a predicate device, and it also complies with the EU Medical Device Regulation (MDR). This dual regulatory approval allows the system to be legally marketed and used in both the United States and the European Union, though specific country-level requirements (e.g., additional local registrations or compliance checks) may still apply. Clinicians and buyers should confirm local regulations before procurement.
Are there different models or sizes available for the Mazor X System, and if so, how might they be tailored to specific surgical needs?
The provided data does not specify distinct models or sizes for the Mazor X System, but its robotic guidance and navigation software are designed to adapt to various spinal and neurosurgical procedures. The system’s flexibility likely allows for customization in terms of surgical planning and execution, though exact variations (e.g., hardware attachments or software modules) would need to be confirmed directly with Mazor Robotics. Buyers should inquire about compatibility with their facility’s specific procedural requirements.
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 | K182077 | Class II | Active |
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Manufacturer
- Manufacturer
- Mazor Robotics Ltd
- FDA Applicant
- Mazor Robotics , Ltd.
Sources (2)
- FDA 510(k) K182077 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026