Manufacturer
Mazor Robotics , Ltd.Mazor X System / Mazor X Stealth Edition
Product code OLO· 21 CFR 882.4560
Product code
Device details
FDA 510(k) registration fields
- K number
- K251316
- Device name
- Mazor X System / Mazor X Stealth Edition
- Company
- Mazor Robotics , Ltd.
- Country / Region
- Israel(IL)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2025-04-29
- Decision date
- 2025-09-11
- Submission type
- Traditional
- Technology type
- Software Navigation(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for Use
The Mazor X is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery. It may be used in open or minimally invasive or percutaneous procedures. Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-arms into a volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects. The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.
Intended Use
The Mazor X is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery. It may be used in open or minimally invasive or percutaneous procedures. Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-arms into a volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects. The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.
Device Description
The Mazor X system combines robotic trajectory guidance with navigated surgical instruments (either guided or free hand navigation) to enable the surgeon to precisely position surgical instruments and/or implants according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT.
Summary parsed at:2026-06-19 05:22:57 UTC
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Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers
Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition
Mazor X System (Mazor X Stealth Edition)
CD Horizon™ Spinal System
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K251316 references 22 predicate/reference devices
Cited as predicate
1Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
1 submission cite K251316 as a predicate
