Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012098629

FEI Number

3012098629

Entity Name

7D SURGICAL ULC

City/State/Country

Toronto Ontario, CA

Establishment Address

60 Scarsdale Road, Unit 118, Toronto Ontario M3B 2R7, CA

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

7D Surgical ULC (Owner Number: 10053763)

Owner / Operator Contact Address

60 Scarsdale Road, Unit 118, Toronto, CA-ON M3B 2R7, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192945

PMA Number

N/A

All Registered Proprietary Names

FLASH EVD System FLASH Navigation System FLASH Navigation System FLASH Navigation System FLASH Navigation System FLASH Navigation System FLASH Navigation System FLASH Navigation System FLASH Navigation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-12
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-04
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-04
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-04
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-05

Official Correspondent

Elena Marenny

US Agent Details

Amira Milutinovic Business: ORTHOFIX LLC Email: AmiraMilutinovic@Orthofix.com Phone: (214) 9372196

Related Public Records

Same Entity

7D Surgical ULC

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

Registration Number	Establishment Name	Location
3002743211	NORTHERN DIGITAL, INC.	WATERLOO Ontario, CA
3009108888	RENISHAW MAYFIELD	Chassieu Rhone, FR
3018708317	MAGNUS MEDICAL INC.	Burlingame, CA, US
2434444	NEURODYNAMICS, INC.	Manhattan, NY, US
3017004815	RENISHAW NEURO SOLUTIONS LTD	Wotton-under-Edge Gloucestershire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012098629. Last updated year: 2026. Please use registration number 3012098629 when referencing this establishment in official correspondence.