Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005075696

FEI Number

3005075696

Entity Name

MAZOR ROBOTICS LTD.

City/State/Country

Caesarea Haifa, IL

Establishment Address

1 HaEshel Street (Building C), Caesarea Business Park, Caesarea Haifa 3079830, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K113228

PMA Number

N/A

All Registered Proprietary Names

Mazor X Mazor X Mazor X System Mazor X Stealth Edition

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-10-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-10-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-03-26
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-03-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-11-10
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-11-10
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-11-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-11-17
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-03-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-03-26

Official Correspondent

No official correspondent registered.

US Agent Details

Alison Webster Business: Medtronic Email: alison.s.webster@medtronic.com Phone: (901) 3992384

Related Public Records

Same Entity

Medtronic, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007042319	HeartWare, Inc.	Miami Lakes, FL, US
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3015192387	CATHWORKS	Newport Beach, CA, US
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005075696. Last updated year: 2026. Please use registration number 3005075696 when referencing this establishment in official correspondence.