BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COMPASS International Innovations, Inc.

    Reg #: 2183671 · FEI: 2183671 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    COMPASS International Innovations, Inc.
    Registration Number
    2183671
    FEI Number
    2183671
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1815 14TH ST. NW, SUITE A
    City
    Rochester
    State
    MN
    ZIP
    55901
    Country
    US

    Regulatory Submissions

    510(k) Number
    K862220

    Owner / Operator

    Firm Name
    COMPASS INTERNATIONAL
    Operator Number
    1318929
    Address
    1815 14TH ST. NW, SUITE A
    City
    Rochester
    State
    MN
    Postal Code
    55901
    Country
    US
    Correspondent
    JON S ROUSU

    Products

    Device Name Product Code
    Neurological Stereotaxic Instrument HAW
    Retractor, Self-Retaining, For Neurosurgery GZT

    Proprietary Names

    COMPASS CT Stereotactic Adaptation Regulus Navigator/CYGNUS-PFS COMPASS Stereotactic Retractor Sys COMPASS Stereotactic Positioning Sy

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device