BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOPOLY, LLC

    Reg #: 3008108789 · FEI: 3008108789 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOPOLY, LLC
    Registration Number
    3008108789
    FEI Number
    3008108789
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7136 Gettysburg Pike
    City
    Fort Wayne
    State
    IN
    ZIP
    46804
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233592

    Owner / Operator

    Firm Name
    BioPoly, LLC
    Operator Number
    10041050
    Address
    7136 Gettysburg Pike
    City
    Fort Wayne
    State
    IN
    Postal Code
    46804
    Country
    US
    Correspondent
    Herb E Schwartz

    Products

    Device Name Product Code
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Prosthesis, Toe, Hemi-, Phalangeal KWD

    Proprietary Names

    BioPoly® Radial Head Implant BioPoly® Lesser Toe Hemiarthroplasty Implant BioPoly® Great Toe Hemiarthroplasty Implant

    Establishment Types

    Manufacture Medical Device