Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K212739
    Device Name
    ActiFlip
    Manufacturer
    Parcus Medical LLC.
    Date Cleared
    2021-10-06

    (37 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Parcus Medical LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Parcus Actiflip is used for fixation of bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, posterior cruciate ligament, pectoralis repari (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction. The Parcus ActiFlip is also intended for fixation of suture (soft tissue) to bone in the foot and ankle for midfoot reconstruction and hindfoot reconstruction with the following procedures: FHL Tendon Transfer, Posterior Tibialis Tendon Transfer, Anterior Tibialis Tendon Transfer.
    Device Description
    The Parcus ActiFlip device consists of a titanium implantable button that is mounted onto an inserter shaft that allows for placement and deployment of the button. ActiFlip is available in three (3) configurations, with or without UHMWPE suture – Naked (without suture), CINCH, WHIP.
    Ask a Question

    Page 1 of 1