BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SI-Restore

    Reg #: 3015422154 · FEI: 3015422154 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    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
    K182919

    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

    Proprietary Names

    SI-Restore

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility