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

    BONE NAIL, KUNTSCHER

    K Number: K911982 · Decision Jul 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    70
    Applicant Total
    5
    Review Days
    84

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    Basic Information

    Device Name
    BONE NAIL, KUNTSCHER
    K Number
    K911982
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3690
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    International Hospital Supply Co.
    Date Received
    May 3, 1991
    Decision Date
    July 26, 1991
    Product Code
    HSD
    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
    HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

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