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

    AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip

    K Number: K192750 · Decision Jan 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    28
    Review Days
    108

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    Basic Information

    Device Name
    AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip
    K Number
    K192750
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Parcus Medical, LLC
    Date Received
    September 30, 2019
    Decision Date
    January 16, 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 Parcus Medical, LLC

    K Number Device Name
    K221502 Parcus Synd-EZ SS
    K221135 X-Twist PEEK Suture Anchor
    K212739 ActiFlip
    K202662 Parcus Titanium Interference Screws
    K202259 Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip
    K201083 Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors
    K193295 Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor
    K192964 Parcus Synd-EZ SS
    K192824 Parcus Knotless AP Suture Anchors
    K191783 Parcus Synd-EZ Ti
    Search all 28 clearances from Parcus Medical, LLC →