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

    Arthrex FiberTak Suture Anchor

    K Number: K221396 · Decision Dec 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    564
    Applicant Total
    110
    Review Days
    223

    Basic Information

    Device Name
    Arthrex FiberTak Suture Anchor
    K Number
    K221396
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arthrex Inc.
    Date Received
    May 13, 2022
    Decision Date
    December 22, 2022
    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 Arthrex Inc.

    K Number Device Name
    K251145 Arthrex PushLock Suture Anchors
    K251453 Arthrex iBalance Partial Knee System
    K243480 SuturePatch Tissue Reinforcement
    K250596 Arthrex FiberTak Suture Anchor
    K243995 Arthrex Humeral Plating System and Cerclage Button
    K250424 Arthrex TightRope Soft Button, RT
    K243344 Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
    K243742 Arthrex DynaNite Nitinol Staples
    K243890 Arthrex Intramedullary Nails
    K242079 Arthrex Elbow Fracture Plating System
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