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

    GROWTH CONTROL PLATING SYSTEM

    K Number: K070823 · Decision May 7, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    7
    Review Days
    42

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    Basic Information

    Device Name
    GROWTH CONTROL PLATING SYSTEM
    K Number
    K070823
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Trauma
    Date Received
    March 26, 2007
    Decision Date
    May 7, 2007
    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 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
    K081243 BIOMET PHOENIX ANKLE NAIL SYSTEM
    K071325 BIOMET VARIABLE LOCKING PLATE SYSTEM