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

    DC ULNAR SHORTENING SYSTEM

    K Number: K073228 · Decision Feb 29, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    7
    Review Days
    106

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    Basic Information

    Device Name
    DC ULNAR SHORTENING SYSTEM
    K Number
    K073228
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthopro, LLC
    Date Received
    November 15, 2007
    Decision Date
    February 29, 2008
    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 Orthopro, LLC

    K Number Device Name
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    K070555 ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES
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