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

    ORTHOPEDIC IMPLANT PLATES

    K Number: K850025 · Decision May 20, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    3
    Review Days
    137

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    Basic Information

    Device Name
    ORTHOPEDIC IMPLANT PLATES
    K Number
    K850025
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Kirkstil Corp., Inc.
    Date Received
    January 3, 1985
    Decision Date
    May 20, 1985
    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 Kirkstil Corp., Inc.

    K Number Device Name
    K850026 ORTHOPEDIC IMPLANT NAILS & PINS
    K850024 ORTHOPEDIC IMPLANT SCREWS