BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SetX Pedicle Screw System

    Reg #: 3011181154 · FEI: 3011181154 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    XENCO MEDICAL LLC
    Registration Number
    3011181154
    FEI Number
    3011181154
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9930 Mesa Rim Road
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170611

    Owner / Operator

    Firm Name
    Xenco Medical, LLC
    Operator Number
    10047563
    Address
    9930 Mesa Rim Road
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Jason Haider

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    SetX Pedicle Screw System

    Establishment Types

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