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510(k) Data Aggregation

    K Number
    K961649
    Date Cleared
    1996-07-16

    (77 days)

    Product Code
    Regulation Number
    888.3040
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Acufex® Tibial Anchor Screw & Spiked Washer is indicated for fixation of soft tissue, such as tendon and ligaments, to bone in orthopedic procedures.

    Device Description

    Acufex® Tibial Anchor Screw & Spiked Washer is a device used in soft tissue to bone fixation. The Tibial Anchor Screw is a two part screw. The outer larger part has cancellous threads, which come in direct contact with bone, and is 9 mm in diameter with a length of 20 - 30 mm. The inner part, 7 mm diameter and 20 - 25 mm length, is used to attach the Spiked Washer directly to the outer part. The spiked washer is 14 - 20 mm in diameter with spikes set at the periphery.

    AI/ML Overview

    I am sorry. This document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. It only contains a 510(k) summary for a medical device called Acufex® Tibial Anchor Screw & Spiked Washer, which describes its features and compares it to similar devices already on the market.

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