BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEX-D2 Posterior Fixation System

    Reg #: 3010020754 · FEI: 3010020754 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NEXT ORTHOSURGICAL
    Registration Number
    3010020754
    FEI Number
    3010020754
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3270 Corporate Vw Ste A
    City
    Vista
    State
    CA
    ZIP
    92081
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190981

    Owner / Operator

    Firm Name
    Next Orthosurgical
    Operator Number
    10042957
    Address
    3270 Corporate View, Suite A
    City
    Vista
    State
    CA
    Postal Code
    92081
    Country
    US
    Correspondent
    Misty Calkins

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    NEX-D2 Posterior Fixation System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198