Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002743211

FEI Number

3002743211

Entity Name

NORTHERN DIGITAL, INC.

City/State/Country

WATERLOO Ontario, CA

Establishment Address

103 RANDALL DRIVE, WATERLOO Ontario N2V 1C5, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

NORTHERN DIGITAL, INC. (Owner Number: 9059739)

Owner / Operator Contact Address

103 RANDALL DRIVE, --, WATERLOO, CA-ON N2V 1C5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K033621

PMA Number

N/A

All Registered Proprietary Names

Disposable Reflective Marker Sphere NDI Passive Sphere

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2010-08-09
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2010-08-09
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2007-12-20

Official Correspondent

No official correspondent registered.

US Agent Details

Jon Ward Business: AJW Technology Consultants, Inc. Email: usagent@ajwtech.com Phone: (813) 6452855

Related Public Records

Same Entity

NORTHERN DIGITAL, INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.

Similar Registrations

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3017004815	RENISHAW NEURO SOLUTIONS LTD	Wotton-under-Edge Gloucestershire, GB
1424263	Isomedix Operations, Inc.	Libertyville, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002743211. Last updated year: 2026. Please use registration number 3002743211 when referencing this establishment in official correspondence.