BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FixxSure® X-Link

    Reg #: 3004719693 · FEI: 3004719693 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    INNOVASIS, INC.
    Registration Number
    3004719693
    FEI Number
    3004719693
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    614 E 3900 S
    City
    SALT LAKE CITY
    State
    UT
    ZIP
    84107
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162143

    Owner / Operator

    Firm Name
    INNOVASIS, INC.
    Operator Number
    9063224
    Address
    614 EAST 3900 SOUTH, --
    City
    Salt Lake City
    State
    UT
    Postal Code
    84107
    Country
    US

    Products

    Device Name Product Code
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH

    Proprietary Names

    FixxSure® X-Link SpineWorks™ FixxSure® X-Link

    Establishment Types

    Manufacture Medical Device