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510(k) Data Aggregation

    K Number
    K014304
    Manufacturer
    Date Cleared
    2002-03-27

    (86 days)

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

    BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S

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

    This device is indicated for use in the general management of fractures and This device is indication for ass litht bearing applications with proper postoperative immobililzation.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the Bone-Lok™ Bioabsorbable Compression Anchor. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    The letter is a notification of the FDA's determination that the device is substantially equivalent to legally marketed predicate devices, allowing Triage Medical, Inc. to market the device. It focuses on regulatory compliance, general controls, and classification.

    Therefore, I cannot provide the requested information based on the input document. The document primarily addresses regulatory clearance rather than detailed performance study results.

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