Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011874573

FEI Number

3011874573

Entity Name

ClaroNav Inc.

City/State/Country

Toronto Ontario, CA

Establishment Address

1140 Sheppard Ave. West, Unit 10, Toronto Ontario M3K 2A2, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ClaroNav Inc. (Owner Number: 10052787)

Owner / Operator Contact Address

1140 Sheppard Ave. West, Unit 10, Toronto, CA-ON M3K 2A2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241327

PMA Number

N/A

All Registered Proprietary Names

Navident Navient Navident Navient Image Guided Navigation system 955-NC-NC cranial Navient system-cranial

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PLV	Dental Stereotaxic Instrument	Dental	Class 2	872.4120	2024-10-25
QRY	Dental Navigation System	Dental	Class 2	872.4120	2024-10-25
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-09-04
PLV	Dental Stereotaxic Instrument	Dental	Class 2	872.4120	2016-10-06
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-02-26

Official Correspondent

No official correspondent registered.

US Agent Details

Sandra Stapleton Email: sandra@claronav.com Phone: (650) 8889705

Related Public Records

Same Entity

ClaroNav 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
K200041	Fiagon GmbH	FlexPointer 1.5 Single Use, FlexTube 3 Single Use	2020-03-10
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

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

Registration Number	Establishment Name	Location
3011764595	X-NAV TECHNOLOGIES, LLC.	Lansdale, PA, US
3012787974	NEOCIS INC	Miami, FL, US
3014552222	Aprios Custom MFG	Vista, CA, US
3006540014	NOBEL BIOCARE DISTRIBUTION CENTER BV	Venlo Limburg, NL
3021736516	NAVIGATE SURGICAL TECHNOLOGIES INC.	Vancouver British Columbia, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011874573. Last updated year: 2026. Please use registration number 3011874573 when referencing this establishment in official correspondence.