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

    ORTHOCORD

    K Number: K123668 · Decision Feb 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    3
    Review Days
    89

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    Basic Information

    Device Name
    ORTHOCORD
    K Number
    K123668
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy Mitek, Inc., A Johnson and Johnson Company
    Date Received
    November 29, 2012
    Decision Date
    February 26, 2013
    Product Code
    NEW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NEW Suture, Surgical, Absorbable, Polydioxanone

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    Other Clearances by Depuy Mitek, Inc., A Johnson and Johnson Company

    K Number Device Name
    K131683 HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
    K122123 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED