Mazor X System / Mazor X Stealth Edition
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251316 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 that combines surgical navigation with operative planning for spinal surgery. It tracks the position of instruments during surgery in relation to the patient's anatomy. The system is designed to support efficient and predictable surgical procedures.
The Mazor X System / Mazor X Stealth Edition is supplied with advanced software, robotic technologies, navigation, and instrumentation. It has been authorized with an FDA 510K clearance. The system is used in spinal surgery and is designed to provide accurate guidance and navigation during procedures.
Frequently asked questions
What is the Mazor X System used for?
The Mazor X System is used in spinal surgery to provide accurate guidance and navigation during procedures, supporting efficient and predictable surgical outcomes.
Is the Mazor X System supplied with software and instrumentation?
Yes, the Mazor X System is supplied with advanced software, robotic technologies, navigation, and instrumentation to support its use in spinal surgery.
What is the regulatory status of the Mazor X System?
The Mazor X System has been authorized with an FDA 510K clearance, indicating that it is substantially equivalent to a predicate device.
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 Robotic Guidance System | Medtronic, Mazor X Stealth Edition Robotic Guidance System - SPINEMarketGroup, Mazor X System / Mazor X Stealth Edition (K251316) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251316 | Class II | Active |
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Manufacturer
- Manufacturer
- Mazor Robotics Ltd
- FDA Applicant
- Mazor Robotics , Ltd.
Sources (1)
- FDA 510(k) K251316 24 fields · synced Sep 23, 2026