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Mazor X System / Mazor X Stealth Edition

Mazor Robotics , Ltd.

Country / Region:Israel (IL)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

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Company

Israel (IL)

Product code

OLO
21 CFR 882.4560

Predicate devices

22

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K251316
Device name
Mazor X System / Mazor X Stealth Edition
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

Predicate devices

22

K251316 references 22 predicate/reference devices

Cited as predicate

1

1 submission cite K251316 as a predicate