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510(k) Data Aggregation

    K Number
    K961578
    Device Name
    SUTURE ANCHOR
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    1996-07-10

    (77 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K954443
    Predicate For
    K973281
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® . Suture Anchor (K954443) are indicated for attachment of soft tissue to bone in shoulder, wrist and hand procedures

    Device Description

    Both the Surgical Dynamics™ Suture Anchor** and the Polv-Medics Lactosorb® . Suture Anchor (K954443) consist of a suture anchor, with polyester suture attached, that is placed into a predrilled bone hole for anchorage of soft tissue.

    AI/ML Overview

    This looks like a 510(k) premarket notification for a medical device (Surgical Dynamics™ Suture Anchor), not an AI/ML powered device. The document describes substantial equivalence to a predicate device, rather than providing acceptance criteria and a study demonstrating performance of an AI/ML model.

    Therefore, I cannot provide the information requested in your prompt as it pertains to AI/ML device studies. The provided text is a regulatory filing focused on establishing similarity to an existing device for market clearance.

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