BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CARPAL ENGAGING WRIST FUSION PLATE

    K Number: K974030 · Decision Jan 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    4
    Review Days
    90

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    Basic Information

    Device Name
    CARPAL ENGAGING WRIST FUSION PLATE
    K Number
    K974030
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Terray Corp.
    Date Received
    October 23, 1997
    Decision Date
    January 21, 1998
    Product Code
    HRS
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HRS Plate, Fixation, Bone

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    Other Clearances by Terray Corp.

    K Number Device Name
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    K003911 TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)
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