BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pro-Link Orthopedic Manual Surgical Instrument

    Reg #: 3007406875 · FEI: 3007406875 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GIZMO PRECISION MEDICAL LLC
    Registration Number
    3007406875
    FEI Number
    3007406875
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6N343 Mission Hills Drive
    City
    St Charles
    State
    IL
    ZIP
    60175
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160066

    Owner / Operator

    Firm Name
    Gizmo Precision Medical LLC
    Operator Number
    10028400
    Address
    6N343 Mission Hills Drive
    City
    St Charles
    State
    IL
    Postal Code
    60175
    Country
    US
    Correspondent
    Angela Batker

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE

    Proprietary Names

    Pro-Link Orthopedic Manual Surgical Instrument

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)