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510(k) Data Aggregation

    K Number
    K081673
    Device Name
    DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE
    Manufacturer
    IONICS MEDICAL CORP.
    Date Cleared
    2008-11-14

    (154 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    IONICS MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dyn-ALIF device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed for use with autogenous bone graft to facilitate fusion. The Dyn-ALIF device is intended for use at either one level or two contiguous levels in the lumbar spine from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had at least six months of non-operative treatment. The device is intended to be used with supplemental internal spinal fixation systems which are cleared by the FDA for use in the lumbar spine.
    Device Description
    The Dyn-ALIF Anterolateral Intervertebral Body Fusion Device is an implantable device manufactured from titanium alloy which is available in the abutting plate interface dimension of 20mm x 30mm and a vertically expandable height ranging from 11mm anterior /9mm posterior to 15mm anterior/13mm posterior to suit the individual anatomic conditions of the patient. The assembled device consists of five components: two abutting plates with hollow threaded shafts, a central turnbuckle sleeve and two locking set screws. The components can be rigidly locked into a variety of heights, with each construct height measured for the individual case
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    K Number
    K011181
    Device Name
    ICS MEDICAL CHARTR OAE WITH TYMP
    Manufacturer
    ICS MEDICAL CORP.
    Date Cleared
    2001-06-25

    (68 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICS MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002985
    Device Name
    ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
    Manufacturer
    ICS MEDICAL CORP.
    Date Cleared
    2000-12-13

    (79 days)

    Product Code
    GWJ
    Regulation Number
    882.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICS MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983667
    Device Name
    IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE
    Manufacturer
    IONICS MEDICAL CORP.
    Date Cleared
    2000-07-05

    (625 days)

    Product Code
    MQP
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    IONICS MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - The Levante Intervertebral Pillar prosthesis is intended for use in the thoracolumbar spine (i.e., T1 to L5) to replace and to restore the height of a diseased vertebral body resected or excised for the treatment of tumor as well as to concomitantly facilitate anterior decompression of the spinal cord and neural tissues. Two contiguous vertebral bodies are the maximum number of bodies the device is intended to replace. The device is intended to be always implanted with adjunctive fixation. - To replace a vertebral body for tumor and to replace or restore the height of a vertebral body due to fracture; for example, burst or compression fractures - To facilitate anterior decompression of the spinal cord and neural structure - To facilitate the reduction of kyphotic deformities
    Device Description
    Not Found
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    K Number
    K991497
    Device Name
    ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
    Manufacturer
    ICS MEDICAL CORP.
    Date Cleared
    1999-07-28

    (90 days)

    Product Code
    GWN
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICS MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used to observe, record and measure eye movements in patients during testing of vestibular function.
    Device Description
    The CHARTR® ENG/VNG Diagnostic System is a computer based medical device consisting of a Computer utilizing the Pentium III processor, Windows 98 Operating System. Computer Monitor, two Display Monitors for viewing eve movements and utilizes the following accessories: Light Bar, Video Goggles, External Isolation Transformer. Video Distribution Amplifier. Caloric Stimulator. Color Printer, Patient Electrodes, and Interconnection Cables.
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    K Number
    K972631
    Device Name
    ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER
    Manufacturer
    ICS MEDICAL CORP.
    Date Cleared
    1997-09-22

    (70 days)

    Product Code
    GWN, 84G
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICS MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used to record and visually display movements of the eyes including nystagmus.
    Device Description
    The VEMR™ Eye Movement Recorder is used to observe or record eye movements on a video monitor or video recording tape respectively. This device consists of: patient eye goggles, a video image splitter/power-supply, a video tape cassette recorder (VCR) video monitor console, and a remote control accessory. There is also a built-in microphone in the eye goggles to provide simultaneous voice recording's on a video recording tape. The patient eye goggles are an opaque, facially worn device fitted with tiny video cameras, infrared light emitting diodes (LED's), and a microphone. The diodes illuminate the eyes for video cameras that produce video signals. These signals are processed by the image processor that essentially allows for simultaneous viewing the video images of both eyes on the video screen. The microphone allows for recording of voices to help document events recorded on video tape. The remote control accessory provides remote control of the various functions (e.g. play, record etc.) on the VCR/video monitor console.
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    K Number
    K960097
    Device Name
    CHARTR EP
    Manufacturer
    ICS MEDICAL CORP.
    Date Cleared
    1997-02-21

    (407 days)

    Product Code
    GWJ
    Regulation Number
    882.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICS MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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