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    K Number
    K012280
    Device Name
    TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2
    Manufacturer
    TRIAGE MEDICAL INC
    Date Cleared
    2001-08-17

    (29 days)

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

    TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2

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

    This device is used for the correction of hallux valgus (bunion) and repair of metatarsal, metacarpal and phalangeal fractures.

    Device Description

    Titanium Compression Anchor System

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Titanium Compression Anchor System". This document confirms that the device is substantially equivalent to a predicate device and can be marketed. It does not contain any information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert qualifications for AI/ML device validation.

    Therefore, I cannot extract the requested information from the provided text. The questions posed are relevant to AI/ML device submissions, which this document is not.

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