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

    VOLAR PLATE SYSTEM

    K Number: K052150 · Decision Sep 8, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    4
    Review Days
    31

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    Basic Information

    Device Name
    VOLAR PLATE SYSTEM
    K Number
    K052150
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dvo Extremity Solutions, LLC
    Date Received
    August 8, 2005
    Decision Date
    September 8, 2005
    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 Dvo Extremity Solutions, LLC

    K Number Device Name
    K073331 DVO EXTENDED ARTICULATION HUMERAL HEADS
    K060988 TOTAL AND HEMI SHOULDER SYSTEM
    K052754 WRIST FUSION PLATE