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

    FR.O.H. CALCANEUS REPAIR SYSTEM

    K Number: K051642 · Decision Aug 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    2
    Applicant Total
    13
    Review Days
    63

    Basic Information

    Device Name
    FR.O.H. CALCANEUS REPAIR SYSTEM
    K Number
    K051642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
    Date Received
    June 20, 2005
    Decision Date
    August 22, 2005
    Product Code
    NDF
    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
    NDF Plate, Fixation, Bone, Non-Spinal, Metallic

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