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

    ORTHOSORB RESORBABLE PINS

    K Number: K111077 · Decision Jul 12, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    207
    Review Days
    85

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    Basic Information

    Device Name
    ORTHOSORB RESORBABLE PINS
    K Number
    K111077
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DePuy Orthopaedics, Inc.
    Date Received
    April 18, 2011
    Decision Date
    July 12, 2011
    Product Code
    OVZ
    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
    OVZ Pin, Fixation, Resorbable, Hard Tissue

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