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510(k) Data Aggregation

    K Number
    K101446
    Device Name
    EMERALD SPINAL SYSTEM
    Manufacturer
    MAZOR SURGICAL TECHNOLOGIES LTD.
    Date Cleared
    2011-01-20

    (241 days)

    Product Code
    MNH, MNI, NKB
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAZOR SURGICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K102130
    Device Name
    TENZING SYSTEM
    Manufacturer
    MAZOR SURGICAL TECHNOLOGIES LTD.
    Date Cleared
    2010-08-26

    (28 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAZOR SURGICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TenZing System is a combination of the SpineAssist System and C-InSight System, allowing the C-InSight application to run on the SpineAssist Workstation: The SpineAssist™ System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. The SpineAssist™ System may be used in either open or percutaneous procedures. The C-InSight software provides a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects particularly in orthopedic applications.
    Device Description
    The TenZing system is a device modification of the SpineAssist system, designed to incorporate both the original SpineAssist system and the C-InSight system in one workstation. The TenZing console is identical to the SpineAssist console. The system is intended to be used in a variety of hospital locations (e.g., OR, trauma unit, etc.). The main components of the TenZing System include: A. Workstation B. SpineAssist accessories: Surgical Accessories Kit . Setup Kit . C. SpineAssist Device D. C-InSight accessories: Spine Target Kit . Extremities Target Kit . E. Image Adaptor F. Spine Assist Disposable kits G. C-InSight Sterile Sheath Disposable kits
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    K Number
    K081672
    Device Name
    C-INSIGHT
    Manufacturer
    MAZOR SURGICAL TECHNOLOGIES LTD.
    Date Cleared
    2008-08-15

    (63 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAZOR SURGICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C-InSight software provides a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects particularly for orthopedic applications.
    Device Description
    C-InSight is a software based product, which converts a sequence of Two-dimensional fluoroscopy images into a 3D volume, intraoperatively. The C-InSight is an add-on to commercially available mobile x-ray systems.
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    K Number
    K073467
    Device Name
    SPINEASSIST SYSTEM
    Manufacturer
    MAZOR SURGICAL TECHNOLOGIES LTD.
    Date Cleared
    2008-05-23

    (165 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAZOR SURGICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpineAssist™ System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. The SpineAssist™ System may be used in either open or percutaneous procedures.
    Device Description
    The SpineAssist™ system is a computer controlled miniature medical image-guided surgery (IGS) system, which serves as a technological platform for solutions that provide unprecedented levels of accuracy, precision and accessibility in performing orthopedic procedures. The SpineAssist™ is designed to assist surgeons in precisely guiding handheld surgical tools in line with a computerized, image-based pre-operative plan along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the SpineAssist device, which positions its articulating arm and tool guide. Using a special bone attachment component (i.e., a clamp and bridge, the Hover-T / Bi-lateral Hover-T bridge, the Bed Mount Hover-T or the Cervical Kit) the SpineAssist device attaches to the bone in the area where the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools according to the computerized, image-based, pre-operative plan. The main components of the SpineAssist™ system include: A. SpineAssist™ device B. Workstation C. Accessories including the Clamp Kit for less invasive procedures, the MIS platforms: Hover-T, Bi-lateral Hover-T, Bed Mount Hover-T and the Cervical Kit, the last one intended for less invasive procedures.
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    K Number
    K063607
    Device Name
    SPINEASSIST SYSTEM
    Manufacturer
    MAZOR SURGICAL TECHNOLOGIES LTD.
    Date Cleared
    2007-08-23

    (262 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAZOR SURGICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpineAssist™ System is indicated for precise positioning of surgical instruments or implants during thoracic and lumbar spinal surgery. The SpineAssist™ system may be used in either open or percutaneous procedures.
    Device Description
    The SpineAssist™ system is a computer controlled miniature medical image-guided surgery (IGS) system which serves as a technological platform for solutions that provide unprecedented levels of accuracy, precision and accessibility in performing orthopedic procedures. The SpineAssist™ is designed to assist surgeons in precisely guiding handheld surgical tools or implants in line with a computerized, image-based pre-operative plan along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the SpineAssist device, which positions its articulating arm and tool guide. Using a special bone attachment component (i.e., a clamp and bridge or the Hover-T bridge) the SpineAssist device attaches to the bone in the area where the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools or implants according to the computerized, image-based, preoperative plan. The main components of the SpineAssist™ system include: - A. SpineAssist™ device - B. Workstation - A. Accessories including clamp, bridge, Hover-T bridge, targets, prism, wedge, etc.
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    K Number
    K051676
    Device Name
    SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES
    Manufacturer
    MAZOR SURGICAL TECHNOLOGIES LTD.
    Date Cleared
    2005-09-08

    (77 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAZOR SURGICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpineAssist System is indicated for precise positioning of surgical instruments during spinal stabilization surgery. The device enables pre-operative planning of the surgical procedure and subsequent spatial positioning and orientation of the surgical tool during intra-operative procedures. The Hover-T Bridge accessory used in conjunction with the SpineAssist device for minimally invasive surgical procedures, is intended for use for lumbar spinal fusion stabilization surgery.
    Device Description
    The SpineAssist device developed by Mazor Surgical Technologies is an accurate imageguided positioning system that extends surgical capability in terms of precision, miniaturization and accessibility. The SpineAssist surgical positioning system assists the surgeon in the operating room to accurately position hand held surgical tools according to a computerized image-based pre-operative plan and to accurately guide surgical tools along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the SpineAssist Device, which positions its articulating arm and tool guide. Using the Hover-T kit, a special bone attachment component, the SpineAssist device attaches to the bone on which the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools in line with the computerized, image-based, pre-operative plan.
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    K Number
    K033413
    Device Name
    SPINEASSIST DEVICE
    Manufacturer
    MAZOR SURGICAL TECHNOLOGIES LTD.
    Date Cleared
    2004-01-07

    (72 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAZOR SURGICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpineAssist is indicated for precise positioning of surgical instruments during spinal fusion stabilization surgery. The device enables pre-operative planning of the surgical procedure and subsequent spatial positioning and orientation of the surgical tool during intra-operative procedures.
    Device Description
    The SpineAssist device is a computer controlled miniature medical image-guided surgery (IGS) system which serves as a technological platform for solutions that provide unprecedented levels of accuracy, precision and accessibility in performing orthopedic procedures. The SpineAssist is designed to assist surgeons in precisely guiding handheld surgical tools in line with a computerized, image-based preoperative plan along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the MSG, which positions its articulating arm and tool guide. Through the bone-attaching procedure, the SpineAssist device attaches to the bone on which the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools in line with the computerized, image-based, pre-operative plan. The main components of the SpineAssist device include: - A. Planning System; - B. Workstation; and - C. Miniature Surgical Guidance System MSG
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