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

    BIOMET PHOENIX ANKLE NAIL SYSTEM

    K Number: K081243 · Decision Jun 27, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    7
    Review Days
    57

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    Basic Information

    Device Name
    BIOMET PHOENIX ANKLE NAIL SYSTEM
    K Number
    K081243
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Trauma
    Date Received
    May 1, 2008
    Decision Date
    June 27, 2008
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

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    Other Clearances by Biomet Trauma

    K Number Device Name
    K091976 BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
    K092078 OPTILOCK PERIARTICULAR PLATING
    K082874 BIODRIVE CANNULATED SCREW SYSTEM
    K081244 LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS
    K071325 BIOMET VARIABLE LOCKING PLATE SYSTEM
    K070823 GROWTH CONTROL PLATING SYSTEM