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

    PLAMP, PLAMP PLATE, PLAMP WITH HOOK

    K Number: K942032 · Decision Jun 13, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    3
    Review Days
    779

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    Basic Information

    Device Name
    PLAMP, PLAMP PLATE, PLAMP WITH HOOK
    K Number
    K942032
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Hospital For Special Surgery
    Date Received
    April 26, 1994
    Decision Date
    June 13, 1996
    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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