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

    WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES

    K Number: K092914 · Decision Dec 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    5
    Review Days
    78

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    Basic Information

    Device Name
    WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES
    K Number
    K092914
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medshape Solutions
    Date Received
    September 22, 2009
    Decision Date
    December 9, 2009
    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 Medshape Solutions

    K Number Device Name
    K101934 DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000
    K101808 SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER
    K091202 WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,
    K083792 WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055