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

    SBI SR MTP TOE IMPLANT

    K Number: K073635 · Decision Mar 19, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    20
    Review Days
    84

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    Basic Information

    Device Name
    SBI SR MTP TOE IMPLANT
    K Number
    K073635
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3730
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Small Bone Innovations, Inc.
    Date Received
    December 26, 2007
    Decision Date
    March 19, 2008
    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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