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510(k) Data Aggregation

    K Number
    K150924
    Device Name
    A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
    Manufacturer
    ANCHOR INNOVATION MEDICAL (A.I.M.)
    Date Cleared
    2015-07-27

    (112 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANCHOR INNOVATION MEDICAL (A.I.M.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A.I.M. Lead Loop Suturing Device is intended for use in securing Spinal Cord Stimulation (SCS) leads and catheters to the fascia or intra-spinous/supra-spinous ligament.
    Device Description
    The A.I.M. Lead Loop Suturing Device is a singular anchor threaded with an adjustable loop of non-absorbable size 0 suture. The suture material is commercially available Ultra-High Molecular Weight Polyethylene or Polyester braid. The anchor is composed of carbon fiber reinforced polyetheretherketone (PEEK OPTIMA®) supplied by Invibio®. The device is provided sterile and pre-loaded in a needle-tipped, disposable-delivery device to facilitate insertion into tissue. A sterile, disposable ancillary instrument is available separately, or included with the Lead Loop Suturing Device, to assist with tensioning the construct and trimming the suture once the appropriate tension is achieved.
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    K Number
    K133770
    Device Name
    A.I.M. KNOTLESS MENISCAL REPAIR DEVICE
    Manufacturer
    ANCHOR INNOVATION MEDICAL (A.I.M.)
    Date Cleared
    2014-06-10

    (181 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANCHOR INNOVATION MEDICAL (A.I.M.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A.I.M. Knotless Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repair, including the repair of meniscal tears.
    Device Description
    The A.I.M. Knotless Meniscal Repair Device is comprised of two implants pre-threaded with commercially available Ultra High Molecular Weight Polyethylene, USP Size 0 suture pre-loaded into a needle delivery device that will allow the surgeon to repair soft tissue, including a meniscal repair. The needle tip may be available straight, curved, and/or reverse-curved.
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