BEUDAMED
    FDA Registration Active 🇺🇸 United States

    keel

    Reg #: 3020703621 · FEI: 3020703621 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MACH MEDICAL
    Registration Number
    3020703621
    FEI Number
    3020703621
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4707 East Park 30 Drive
    City
    Columbia City
    State
    IN
    ZIP
    46725
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152298

    Owner / Operator

    Firm Name
    Mach Medical, LLC
    Operator Number
    10082639
    Address
    4707 East Park 30 Drive
    City
    Columbia City
    State
    IN
    Postal Code
    46725
    Country
    US
    Correspondent
    Steven J Leins

    Products

    Device Name Product Code
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH

    Proprietary Names

    keel

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)