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    K Number
    K132461
    Device Name
    A.I.M. SUTURE ANCHOR
    Manufacturer
    ANCHOR INNOVATION MEDICAL, INC.
    Date Cleared
    2013-10-16

    (70 days)

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

    ANCHOR INNOVATION MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A.I.M.™ Suture Anchor is intended for use in arthroscopic, mini-open or open surgical procedures for fixation of soft tissue to bone. The A.I.M. ™ Suture Anchor is intended for use in the following applications: Ankle: Mid-foot Reconstruction Foot: Hallux valgus reconstruction Hand: Ulnar or lateral collateral ligament reconstruction Wrist: Scapholunate ligament reconstruction
    Device Description
    The implant system includes a 1.7mm diameter PEEK (polyether-etherketone) anchor. pre-mounted on a disposable inserter. The anchor is preloaded with USP size 0 Ultra High Molecular Weight Polyethylene suture. The device is designed to be inserted into a pre-formed hole using a single use disposable awl
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