NSE-AUTOMATECH

FDA Device Registration & Listing · Granby Quebec, CA · Registration 3009293341

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009293341
FEI Number
3009293341
Entity Name
NSE-AUTOMATECH
City/State/Country
Granby Quebec, CA
Establishment Address
520 Rutherford, Granby Quebec J2G 0B2, CA
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
NSE-Automatech (Owner Number: 10043357)
Owner / Operator Contact Address
520 Rutherford, Granby, CA-QC J2G 0B2, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Navitrack -Partial Hip Resurfacing Navitrack OS Knee Universal Navitrack OS Unicond Knee Universal iASSIST X-PSI FEMUR CUT BLOCK BASE Navitrack OS Knee Universal ROSA PARTIAL KNEE SYSTEM iASSIST iASSIST Knee System Navitrack-CT Free Cup

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2013-02-07
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2013-02-07
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2013-02-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-23
OOG Knee Arthroplasty Implantation System Orthopedic Class 2 888.3560 2021-06-28
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-06-28
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-06-28
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-06-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2013-02-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-04-21
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-02-08
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-02-08
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-02-08
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2013-02-07
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2013-02-07

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

NSE-Automatech
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009293341. Last updated year: 2026. Please use registration number 3009293341 when referencing this establishment in official correspondence.
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