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

    MODIFIED ROG SUTURE ANCHOR

    K Number: K112991 · Decision Dec 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    564
    Applicant Total
    5
    Review Days
    63

    Basic Information

    Device Name
    MODIFIED ROG SUTURE ANCHOR
    K Number
    K112991
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ROG SPORTS MEDICINE, INC.
    Date Received
    October 6, 2011
    Decision Date
    December 8, 2011
    Product Code
    MBI
    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

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    Other Clearances by ROG SPORTS MEDICINE, INC.

    K Number Device Name
    K113299 ROG SUTURE ANCHOR
    K111590 ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR
    K110230 ROG KNOTLESS SUTURE ANCHOR
    K110229 ROG SUTURE ANCHOR 5.5MM, 2.9MM