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

    KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE

    K Number: K083609 · Decision Mar 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    7
    Review Days
    88

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    Basic Information

    Device Name
    KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE
    K Number
    K083609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kfx Medical
    Date Received
    December 8, 2008
    Decision Date
    March 6, 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 Kfx Medical

    K Number Device Name
    K120841 APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR
    K101175 KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER
    K081598 SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE
    K080229 5.5 MM SUTURE LOCK BONE SCREW ANCHOR
    K072063 KFX TISSUE FIXATION SYSTEM AND ACCESSORIES
    K061294 KFX KNOTLESS FIXATION SYSTEM