BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOFUSION MEDICAL

    Reg #: 3015422154 · FEI: 3015422154 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOFUSION MEDICAL
    Registration Number
    3015422154
    FEI Number
    3015422154
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4020 S Industrial Drive, Ste 135
    City
    Austin
    State
    TX
    ZIP
    78744
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200868

    Owner / Operator

    Firm Name
    Biofusion Medical
    Operator Number
    10059912
    Address
    4020 S Industrial Drive Suite 135
    City
    Austin
    State
    TX
    Postal Code
    78744
    Country
    US
    Correspondent
    Rylan Reed

    Products

    Device Name Product Code
    Sacroiliac Joint Fixation OUR

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility