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

    PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS

    K Number: K113730 · Decision Jan 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    564
    Applicant Total
    14
    Review Days
    29

    Basic Information

    Device Name
    PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS
    K Number
    K113730
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    PARCUS MEDICAL, LLC
    Date Received
    December 19, 2011
    Decision Date
    January 17, 2012
    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 PARCUS MEDICAL, LLC

    K Number Device Name
    K162198 GFS Ultimate
    K152711 Parcus GFS Naked
    K133757 GFS II STANDARD, GFS II LARGE, GFS MIMI
    K122805 PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR
    K120942 PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC
    K111000 PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
    K102326 PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR
    K102162 PARCUS PEEK CF PUSH-IN SUTURE ANCHOR
    K091094 PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264
    K091093 PARCUS PPEK CF INTERFERENCE SCREW
    Search all 14 clearances from PARCUS MEDICAL, LLC →