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

    FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT

    K Number: K112481 · Decision Apr 9, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    15
    Applicant Total
    7
    Review Days
    224

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    Basic Information

    Device Name
    FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
    K Number
    K112481
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3810
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascension Orthopedic
    Date Received
    August 29, 2011
    Decision Date
    April 9, 2012
    Product Code
    KXE
    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
    KXE Prosthesis, Wrist, Hemi-, Ulnar

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