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

    Dunamis PunchTac Suture Anchors

    K Number: K193245 · Decision Feb 14, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    6
    Review Days
    81

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    Basic Information

    Device Name
    Dunamis PunchTac Suture Anchors
    K Number
    K193245
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dunamis, LLC
    Date Received
    November 25, 2019
    Decision Date
    February 14, 2020
    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 Dunamis, LLC

    K Number Device Name
    K191319 Dunamis Fixation Button System
    K160996 Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
    K153746 Dunamis Force DFX Tensile Tape
    K151220 Dunamis Interference Screw
    K150327 Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2