BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HARDY MACHINE, LLC

    Reg #: 3009794117 · FEI: 3009794117 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    HARDY MACHINE, LLC
    Registration Number
    3009794117
    FEI Number
    3009794117
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2326 N PENN RD
    City
    Hatfield
    State
    PA
    ZIP
    19440
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191391

    Owner / Operator

    Firm Name
    Hardy Machine Inc
    Operator Number
    10045208
    Address
    2326 North Penn Rd
    City
    Hatfield
    State
    PA
    Postal Code
    19440
    Country
    US

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)