BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Spine & Trauma 3D Navigation

    Reg #: 8043933 · FEI: 3002619595 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BRAINLAB AG
    Registration Number
    8043933
    FEI Number
    3002619595
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Olof-Palme-Strasse 9
    City
    Munich Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K212245

    Owner / Operator

    Firm Name
    Brainlab AG
    Operator Number
    9004547
    Address
    Olof-Palme-Strasse 9
    City
    Munich
    State
    Bavaria
    Postal Code
    81829
    Country
    DE

    US Agent

    Business Name
    BRAINLAB, INC.
    Contact Name
    Paul Neil
    Address
    5 Westbrook Corporate Ctr Ste 1000
    City
    WESTCHESTER
    State
    IL
    ZIP
    60154
    Country
    US
    Email
    [email protected]
    Phone
    708 4091343

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Spine & Trauma 3D Navigation Elements Screw Planning Spine Spine & Trauma Navigation System Elements Spine Screw Planning Navigation Software Spine& Trauma 3D Spine Planning ADAPTER LONG FOR PATIENT REFERENCE CLAMP DRILL BIT 2.4 MM AO SHANK DRILL BIT 2.6 MM AO SHANK DEPTH CONTROL DRILL BIT 3.2 MM AO SHANK INSTRUMENT ADAPTER CLAMP STARLINK SIZE XL INSTRUMENT ADAPTER CLAMP STARLINK SIZE L INSTRUMENT ADAPTER CLAMP STARLINK SOFTGRIP SIZE XL DRILL BIT 4.5 MM AO SHANK DRILL BIT 2.6 MM DEPTH CONTROL (200 MM) DRILL BIT 2.4 MM AO SHANK DEPTH CONTROL DRILL BIT 3.2 MM DEPTH CONTROL (200 MM) INSTRUMENT ADAPTER CLAMP STARLINK SIZE S DRILL BIT 2.6 MM AO SHANK INSTRUMENT ADAPTER CLAMP STARLINK SOFTGRIP SIZE L DRILL BIT 3.2 MM AO SHANK DEPTH CONTROL INSTRUMENT ADAPTER CLAMP STARLINK SIZE M

    Establishment Types

    Manufacture Medical Device