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510(k) Data Aggregation

    K Number
    K132611
    Device Name
    MICROTABLE SYSTEM
    Manufacturer
    FRED HAER COMPANY, INC.
    Date Cleared
    2014-03-06

    (198 days)

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

    FRED HAER COMPANY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microtable System is intended to be used with commercially available stereotactic systems for intra-cranial and neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the cranium, brain, or nervous system.
    Device Description
    The Microtable System is a patient-specific surgical adapter, designed to be secured on a skull-based anchor mounting set to hold and align surgical instruments with patient anatomy and to allow selected targets to be reached with sub-millimeter accuracy. A Microtable System comprises an assembled Microtable, mounting hardware and tools, and cleaning and sterilization cases. The Microtable comprises the tabletop, legs, and an instrument mounting interface. The tabletop is designed specifically for the patient using the commercially available WayPoint™ Planning and Design software. Once the patient-specific tabletop is designed, the file is sent FHC, Inc. or to a qualified FHC OEM that will manufacture the tabletop using a CNC (Computer Numeric Controlled) mill. Each tabletop is patient-specific by milling at least three parallel leg holes and a hole for the instrument interface in a planar sheet of polycarbonate or Ultem. A qualified technician installs legs with appropriate lengths and rigidly attaches them to the tabletop along with the instrument interface. After fabrication and assembly, the tabletop is dimensionally verified to ensure that it meets all of the specifications and is shipped to the hospital for sterilization and use.
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