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    FDA Registration Active 🇩🇪 Germany

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    Reg #: 8043933 · FEI: 3002619595 · Expires 2025
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    Products
    1
    Proprietary Names
    24
    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
    K221618

    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 Navigation Navigation Software Spine & Trauma Spine & Trauma Navigation Alignment Software Spine CIRQ ROBOTIC TRACKING ARRAY 10 Cirq Robotic Disposable Kinematic Unit DRILL BIT 4.5 MM DEPTH CONTROL 0–60 MM Alignment Guide Tube Spine 2.4/10 Alignment Trocar Spine 2.4 Alignment Depth Control Spine Alignment System Spine Cirq Robotic Instrument Holder Spine Cirq Arm System Alignment Trocar Spine 6/10 Alignment Guide Tube Spine 3.2/10 Alignment Trocar Spine 3.2 DRILL BIT 4.5 MM DEPTH CONTROL 60-100 MM Alignment Bone Anchor Cranial 2.1/3.8 Alignment Trocar Spine 2.6 DRILL BIT 3.2 MM DEPTH CONTROL 60-100 MM Alignment Guide Tube Spine 2.6/10 Cirq Robotic Depth Tracking Array black Cirq Robotic Tracking Array Spine 10 Cirq Robotic Depth Tracking Array beige

    Establishment Types

    Manufacture Medical Device