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510(k) Data Aggregation

    K Number
    K030031
    Device Name
    SOFT TISSUE ANCHORING WASHERS
    Manufacturer
    ACCU-SPEED, INCORPORATED
    Date Cleared
    2003-01-28

    (25 days)

    Product Code
    KGS
    Regulation Number
    878.4930
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCU-SPEED, INCORPORATED

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

    The Soft Tissue Anchoring Washers [washers], [washer, bolt nut] Indications For Use: are to be used for anchoring soft tissue to bone.

    Device Description

    Soft Tissue Anchoring Washers [washers], [washer, bolt nut]

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA for a device called "Soft Tissue Anchoring Washers." It is a regulatory letter determining substantial equivalence to a predicate device.

    The provided text does not contain any information regarding clinical studies, acceptance criteria, or performance data of the device. It is a regulatory approval letter, not a device study report. Therefore, I cannot extract the requested information.

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