BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TRAPEZIO-METACARPAL JOINT SPACER

    K Number: K790508 · Decision Apr 10, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    32

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    Basic Information

    Device Name
    TRAPEZIO-METACARPAL JOINT SPACER
    K Number
    K790508
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3770
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Scientific Data Systems Israel, Ltd.
    Date Received
    March 9, 1979
    Decision Date
    April 10, 1979
    Product Code
    KYI
    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
    KYI Prosthesis, Wrist, Carpal Trapezium

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