BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    C-ARM ADAPTER SIEMENS CIOS SPIN RIGHT

    Reg #: 8043933 · FEI: 3002619595 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    62
    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
    K183605

    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

    C-ARM ADAPTER SIEMENS CIOS SPIN RIGHT INSTRUMENT TRACKING ARRAY S&T (SIZE ML) INSTRUMENT TRACKING ARRAY STARLINK SIZE XL INSTRUMENT ADAPTER CLAMP STARLINK SIZE XL Tissue Protection Sleeve Grip AWL (4 MM) FOR OPEN SURGERY C-ARM ADAPTER ZIEHM RFD 3D RIGHT REFLECTIVE DISKS FLUORO KIT REV2-21 PCS INSTRUMENT TRACKING ARRAY STARLINK SIZE M PATIENT REFERENCE ARRAY Y-GEOMETRY X-PRESS INSTRUMENT ADAPTER CLAMP STARLINK SIZE L ADAPTER FOR SURGICAL MOTOR SYSTEM INSTRUMENT ADAPTER CLAMP STARLINK SOFTGRIP SIZE XL CHISEL LONG FOR OPEN SURGERY Drill Guide Depth Control Insertable INSTRUMENT TRACKING ARRAY S&T 3-MARKER INSTRUMENT TRACKING ARRAY STARLINK SIZE ML C-ARM ADAPTER GE OEC 3D LEFT Drill Guide Depth Control HANDLE UNIVERSAL FOR OPEN SURGERY INSTRUMENT TRACKING ARRAY S&T (SIZE L) BONE FIXATOR 2-PIN X-PRESS CIRQ Curve Navigation 17700 Spine and Trauma 3D Navigation Mechatronic Arm Mechatronic VarioGuide Surgical Base System - SBS Kick 2 EM Navigation Station C-ARM REFERENCE UNIT LEFT Drill Guide Compact Handle 4 Markers DISP FIXATION PIN 4 x 125 MM (10 PCS) C-ARM ADAPTER SIEMENS CIOS SPIN LEFT PROBE CURVED (4.5 MM) FOR OPEN SURGERY INSTRUMENT ADAPTER CLAMP STARLINK SIZE M INSTRUMENT ADAPTER STARLINK EXTENSION 50 MM Drill Guide Depth Control (200mm) C-ARM ADAPTER GE OEC 3D RIGHT CALIBRATION PHANTOM ICT PROBE STRAIGHT (3.5 MM) FOR OPEN SURGERY INSTRUMENT ADAPTER STARLINK ANGLED 45° Guide Tube Pedicle Access Needle (1.8 mm) Disposable Trocar Insert Pedicle Access Needle (5 PCS) ADAPTER LONG FOR PATIENT REFERENCE CLAMP C-ARM ADAPTER ZIEHM RFD 3D LEFT PROBE STRAIGHT (4.5 MM) FOR OPEN SURGERY Instrument Calibration Matrix HANDLE GEARSHIFT FOR OPEN SURGERY Drill Guide Handle INSTRUMENT TRACKING ARRAY STARLINK SIZE L Cirq Instrument Holder Module Cirq Instrument Holder Spinal Drilling CHISEL SHORT FOR OPEN SURGERY AWL (3 MM) FOR OPEN SURGERY INSTRUMENT ADAPTER CLAMP STARLINK SIZE S C-ARM REFERENCE UNIT RIGHT Drill Guide Handle 4-Marker RADIOLUCENT DRAPELINK INTERFACE FOR CALIBRATION PHANTOM INTRAOPERATIVE CT INSTRUMENT TRACKING ARRAY S&T 4-MARKER INSTRUMENT ADAPTER CLAMP STARLINK SOFTGRIP SIZE L PATIENT REFERENCE ARRAY T-GEOMETRY X-PRESS ADHESIVE REFLECTIVE FLAT MARKERS (10PCS)

    Establishment Types

    Manufacture Medical Device