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

    KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER

    K Number: K101175 · Decision May 20, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    7
    Review Days
    23

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    Basic Information

    Device Name
    KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER
    K Number
    K101175
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kfx Medical
    Date Received
    April 27, 2010
    Decision Date
    May 20, 2010
    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
    K083609 KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE
    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