Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K201229
    Device Name
    Intai Anatomic Locking Plate and Screw System
    Manufacturer
    Intai Technology Corporation
    Date Cleared
    2022-03-11

    (673 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Intai Technology Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intai Anatomy Locking Plate and Screw System is provided non-sterile. The system is intended for use in fixation of fractures to the various bones, including; clavicle, radius, ulna, humerus, femur, tibia, fibula, and acetabulum for adults. This system is not indicated for use in the spine.
    Device Description
    The Intai Anatomical Locking Plate and Screw System offers anatomically contoured plates for use with non-locking and locking screws. The plates are provided with locking holes as well as holes for cortex screws to enhance compression pressure. With the combination of locking and compression technology, the system further ensures the stability of the implant devices.
    Ask a Question
    K Number
    K180523
    Device Name
    INTAI Surgery Navigation System
    Manufacturer
    Intai Technology Corporation
    Date Cleared
    2019-09-20

    (570 days)

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

    Intai Technology Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INTAI Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include but are not limited to: Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.
    Device Description
    The INTAI Surgery Navigation System, also known as an image guided system, is comprised of navigation cart, software and its accessories. The system uses wireless optical tracking technology to identify the position of instruments relative to the patient's anatomy and displays such position on preoperative or intraoperative images of the patient. The images can help guide the surgeons during spinal surgical procedures, such as spinal fusion. The software links all system components and provides several application modules for trajectory planning, image registration, instrument auto-identification and real-time navigation.
    Ask a Question

    Page 1 of 1