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510(k) Data Aggregation

    K Number
    K011583
    Device Name
    SPIKED WASHER
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2002-01-30

    (252 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K033303,K092381,K192745
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Synthes Spiked Washer is intended for use in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.

    Device Description

    The Spiked Washer is available in the following sizes: 8.0 mm OD / 3.2mm ID (6 spikes), 13.5 mm OD / 4.0 mm ID (8 spikes), and 13.5 mm OD / 6.0 mm ID (8 spikes). The spikes provide a link between the washer and the ligament, with flats at the base of each spike to limit penetration into the ligament and prevent excessive compression. The Spiked Washer is manufactured from a polyetheretherketone resin containing 6% barium sulfate.

    AI/ML Overview

    The provided text is a 510(k) premarket notification summary and a letter from the FDA regarding the Synthes Spiked Washer. It primarily discusses the device description, intended use, material, classification, and substantial equivalence to a predicate device.

    However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. Therefore, I cannot provide the requested information. The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance data against a set of acceptance criteria.

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