BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Paradigm System Model 1100006

    Reg #: 3003500271 · FEI: 3003500271 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MIDWEST PRODUCTS AND ENGINEERING
    Registration Number
    3003500271
    FEI Number
    3003500271
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10597 W Glenbrook Ct
    City
    Milwaukee
    State
    WI
    ZIP
    53224
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243258

    Owner / Operator

    Firm Name
    Midwest Products and Engineering
    Operator Number
    10043161
    Address
    10597 Glenbrook Ct
    City
    Milwaukee
    State
    WI
    Postal Code
    53224
    Country
    US
    Correspondent
    Jim Gartzke

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Paradigm System Model 1100006 Paradigm System Paradigm General Instrument Set 1200009

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)