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510(k) Data Aggregation

    K Number
    K092371
    Device Name
    SWIFT-LOCK ANCHOR, MODEL 1192
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2009-12-23

    (140 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    K111462,K140272
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

    The Swift-Lock™ anchor is intended to be an accessory to the leads component of ANS SCS systems functioning to secure the lead to the fascia or interspinous/supra-spinous ligament.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or studies proving device performance. The document is an FDA 510(k) clearance letter for a medical device (Swift-Lock™ Anchor) and an "Indications for Use Statement."

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given text.

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