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

    DISTAL RADIUS FRACTURE REPAIR SYSTEM

    K Number: K023007 · Decision Dec 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    10
    Review Days
    87

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    Basic Information

    Device Name
    DISTAL RADIUS FRACTURE REPAIR SYSTEM
    K Number
    K023007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hand Innovations, Inc.
    Date Received
    September 9, 2002
    Decision Date
    December 5, 2002
    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 Hand Innovations, Inc.

    K Number Device Name
    K050932 DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
    K042059 SHOULDER FIXATION SYSTEM
    K041157 MODIFICATION TO SMALL BONE FIXATION SYSTEM
    K041081 FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
    K033406 SMALL BONE FIXATION SYSTEM
    K032705 DISTAL RADIUS FRACTURE REPAIR SYSTEM
    K030198 HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM
    K013424 INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND
    K002775 DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM