BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    7D SURGICAL ULC

    Reg #: 3012098629 · FEI: 3012098629 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    7D SURGICAL ULC
    Registration Number
    3012098629
    FEI Number
    3012098629
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    60 Scarsdale Road, Unit 118
    City
    Toronto Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K242480

    Owner / Operator

    Firm Name
    7D Surgical ULC
    Operator Number
    10053763
    Address
    60 Scarsdale Road, Unit 118
    City
    Toronto
    State
    Ontario
    Postal Code
    M3B 2R7
    Country
    CA
    Correspondent
    Elena Marenny

    US Agent

    Business Name
    ORTHOFIX LLC
    Contact Name
    Amira Milutinovic
    Address
    3451 Plano Pkwy
    City
    Lewisville
    State
    TX
    ZIP
    75056
    Country
    US
    Email
    [email protected]
    Phone
    214 9372196

    Products

    Device Name Product Code
    Neurological Stereotaxic Instrument HAW
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    FLASH EVD System FLASH Navigation System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility