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510(k) Data Aggregation

    K Number
    K063275
    Device Name
    DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07)
    Manufacturer
    TERRAY CORP.
    Date Cleared
    2007-07-27

    (270 days)

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

    TERRAY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K003911
    Device Name
    TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)
    Manufacturer
    TERRAY CORP.
    Date Cleared
    2001-03-13

    (84 days)

    Product Code
    KWP
    Regulation Number
    888.3050
    Why did this record match?
    Applicant Name (Manufacturer) :

    TERRAY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K003629
    Device Name
    MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03
    Manufacturer
    TERRAY CORP.
    Date Cleared
    2001-02-22

    (90 days)

    Product Code
    KWD
    Regulation Number
    888.3730
    Why did this record match?
    Applicant Name (Manufacturer) :

    TERRAY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K974030
    Device Name
    CARPAL ENGAGING WRIST FUSION PLATE
    Manufacturer
    TERRAY CORP.
    Date Cleared
    1998-01-21

    (90 days)

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

    TERRAY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The various clinical indications for wrist arthrodesis are at the discretion of the surgeon but in general include: - rheumatoid wrist deformities requiring restoration of alignment and stability - carpal instabilities - severe unremitting wrist pain related to motion of the carpus - other damage to the wrist joint including post-traumatic arthrosis, infection and tumor resection.
    Device Description
    Carpal Engaging Wrist Fusion Plate
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