BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZIP ULTRA MIS Interspinous Fusion System

    Reg #: 3020417298 · FEI: 3020417298 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Aurora Spine Manufacturing
    Registration Number
    3020417298
    FEI Number
    3020417298
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3146 Tiger Run Ct, Suite 116
    City
    Carlsbad
    State
    CA
    ZIP
    92010
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133091

    Owner / Operator

    Firm Name
    Aurora Spine
    Operator Number
    10045511
    Address
    1930 Palomar Point Way, Ste 103
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Laszlo Garamszegi

    Products

    Device Name Product Code
    Spinous Process Plate PEK

    Proprietary Names

    ZIP ULTRA MIS Interspinous Fusion System ZIP MIS Interspinous Fusion System SILO TFX

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)