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510(k) Data Aggregation

    K Number
    K010738
    Device Name
    CANNULATED PLUS SCREW SYSTEM
    Manufacturer
    ORTHOMATRIX, INC.
    Date Cleared
    2001-08-01

    (142 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOMATRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001254
    Device Name
    ORTHOMATRIX, INC. CERCLAGE SYSTEM
    Manufacturer
    ORTHOMATRIX, INC.
    Date Cleared
    2000-12-13

    (238 days)

    Product Code
    JDQ
    Regulation Number
    888.3010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOMATRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K992850
    Device Name
    MAGELLAN TIBIAL INTRAMEDULLARY NAIL
    Manufacturer
    ORTHOMATRIX, INC.
    Date Cleared
    2000-03-10

    (199 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOMATRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MAGELLAN™ Intramedullary Tibial Nail System is indicated for use in long bone shaft fractures of the tibia which require stabilization of the axis of the bone. These include shaft fractures, segmented fractures, fractures with bone loss, comminuted fractures, proximal and distal fractures, nonunions and malunions.
    Device Description
    Magellan Tibial Intramedullary Nail
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    K Number
    K992856
    Device Name
    MAGELLAN HUMERAL INTRAMEDULLARY NAIL
    Manufacturer
    ORTHOMATRIX, INC.
    Date Cleared
    2000-03-10

    (199 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOMATRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MAGELLAN™ Intramedullary Humeral Nail System is indicated for use in long bone shaft fractures of the humerus which require stabilization of the axis of the bone. These include shaft fractures, segmented fractures, fractures with bone loss, comminuted fractures, proximal and distal fractures, non-unions and malunions.
    Device Description
    Not Found
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