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

    METAL HEMI IMPLANT

    K Number: K071243 · Decision May 23, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    7
    Review Days
    20

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    Basic Information

    Device Name
    METAL HEMI IMPLANT
    K Number
    K071243
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3730
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthopro, LLC
    Date Received
    May 3, 2007
    Decision Date
    May 23, 2007
    Product Code
    KWD
    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
    KWD Prosthesis, Toe, Hemi-, Phalangeal

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    Other Clearances by Orthopro, LLC

    K Number Device Name
    K122936 ANKLE TRAUMA SYSTEM
    K113006 I-FUSE HAMMER TOE SYSTEMS
    K093055 CSTS SCREW
    K073228 DC ULNAR SHORTENING SYSTEM
    K070555 ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES
    K062908 ORTHROPRO HEMI TOE