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

    ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS

    K Number: K120360 · Decision May 29, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    6
    Review Days
    113

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    Basic Information

    Device Name
    ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS
    K Number
    K120360
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho Solutions Limited
    Date Received
    February 6, 2012
    Decision Date
    May 29, 2012
    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 Ortho Solutions Limited

    K Number Device Name
    K141784 ORTHO SOLUTIONS ULTOS PLATING SYSTEM
    K121575 OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
    K111678 ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS
    K110895 ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
    K102743 ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES