BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TransLoc 3D

    Reg #: 3013912820 · FEI: 3013912820 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FOUNDATION FUSION SOLUTIONS, LLC
    Registration Number
    3013912820
    FEI Number
    3013912820
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11916 S Oxford Ave, SUITE 206
    City
    Tulsa
    State
    OK
    ZIP
    74137
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211496

    Owner / Operator

    Firm Name
    Foundation Fusion Solutions, LLC
    Operator Number
    10058181
    Address
    11916 S OXFORD AVE, SUITE 206
    City
    Tulsa
    State
    OK
    Postal Code
    74137
    Country
    US
    Correspondent
    Robert Compton

    Products

    Device Name Product Code
    Sacroiliac Joint Fixation OUR

    Proprietary Names

    TransLoc 3D

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198