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

    INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND

    K Number: K013424 · Decision Dec 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    283
    Registration Numbers
    283
    Same Product Code
    203
    Applicant Total
    10
    Review Days
    66

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    Basic Information

    Device Name
    INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND
    K Number
    K013424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hand Innovations, Inc.
    Date Received
    October 15, 2001
    Decision Date
    December 20, 2001
    Product Code
    HTY
    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
    HTY Pin, Fixation, Smooth

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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
    K023007 DISTAL RADIUS FRACTURE REPAIR SYSTEM
    K002775 DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM