BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MACH MEDICAL

    Reg #: 3020703621 · FEI: 3020703621 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    MACH MEDICAL
    Registration Number
    3020703621
    FEI Number
    3020703621
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4707 East Park 30 Drive
    City
    Columbia City
    State
    IN
    ZIP
    46725
    Country
    US

    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
    Stephen Rozow

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Rasp HTR
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Staple, Fixation, Bone JDR
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Femurs RASP keel Knee O.S. Inserter Assembly Biopoly Radial Head Stem Saber C NVS Tibial Tray TMINI Microport Tibial Cones

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)