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510(k) Data Aggregation

    K Number
    K990816
    Device Name
    AVCORE SYSTEM
    Manufacturer
    MODULAR CUTTING SYSTEMS, INC.
    Date Cleared
    1999-09-24

    (197 days)

    Product Code
    HWE
    Regulation Number
    878.4820
    Why did this record match?
    Applicant Name (Manufacturer) :

    MODULAR CUTTING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AV Core System is a system of cannulated trephines and drills used to obtain and insert a contoured bone graft into a matched hole in the femoral head. The use of the system is indicated for patients suffering from Avascular necrosis, in which the head does not suffer from collapse or degenerative changes.
    Device Description
    The AvCore System comprises of a series of trephines and purchased canulated drill bits of matched size, used to obtain a appropriate sized and contoured bone graft in the treatment of avascular necrosis of the femoral head. The device is classified under the nomenclature of drills, burs, Trephines & accessories ( compound, powered). The product code is 84HBF and regulation number 882:4305 and is a Class II device.
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    K Number
    K991037
    Device Name
    EUCLID REDUCTION AND GUIDANCE SYSTEM
    Manufacturer
    MODULAR CUTTING SYSTEMS, INC.
    Date Cleared
    1999-06-23

    (86 days)

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

    MODULAR CUTTING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Euclid Reduction and Positioning System is an adjunct to any intramedullary rod to aid in both the reduction of a femur fracture and to aid in the targeting of the distal screws placed across the rod. It is considered to aid in any type femur fracture for which intramedullary rod fixation is indicated.
    Device Description
    Not Found
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