BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FixxSure X-Link

    Reg #: 3005471884 · FEI: 3005471884 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SPINEWORKS, LLC
    Registration Number
    3005471884
    FEI Number
    3005471884
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    831 N 100 E
    City
    Spanish Fork
    State
    UT
    ZIP
    84660
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081331

    Owner / Operator

    Firm Name
    SPINEWORKS, LLC
    Operator Number
    9077250
    Address
    614 E 3900 S
    City
    Salt Lake City
    State
    UT
    Postal Code
    84107
    Country
    US
    Correspondent
    Michael Thomas

    Products

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

    Proprietary Names

    FixxSure X-Link

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility