BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    zLOCK Lumbar Facet Fixation System

    Reg #: 3031232974 · FEI: 3031232974 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ZygoFix
    Registration Number
    3031232974
    FEI Number
    3031232974
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    17 Tchelet Street, Misgav Industrial Park
    City
    D.N. Misgav Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K240085

    Owner / Operator

    Firm Name
    Qsite
    Operator Number
    10090737
    Address
    31 Haavoda Street
    City
    Binyamina
    State
    Northern
    Postal Code
    3054431
    Country
    IL
    Correspondent
    Yoram Levy

    US Agent

    Business Name
    Qsite
    Contact Name
    Tova Rivnay
    Address
    77 Dorcar Rd.
    City
    Newton
    State
    MA
    ZIP
    02459
    Country
    US
    Email
    [email protected]
    Phone
    512 5354930

    Products

    Device Name Product Code
    System, Facet Screw Spinal Device MRW

    Proprietary Names

    zLOCK Lumbar Facet Fixation System

    Establishment Types

    Manufacture Medical Device