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510(k) Data Aggregation

    K Number
    K012818
    Device Name
    HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
    Manufacturer
    TRIAGE MEDICAL INC
    Date Cleared
    2001-11-20

    (90 days)

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

    HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX

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

    These devices are used for the correction of hallux valgus (bunion) and repair of metatarsal, metacarpal and phalangeal fractures.

    Device Description

    Helical Compression Anchor, Cannulated, Single and Double Helix

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Triage Medical, Inc. Helical Compression Anchor, Cannulated." It is not a study or a report detailing acceptance criteria and device performance. Therefore, I cannot extract the requested information from the provided text.

    The letter simply states that the FDA has reviewed the premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain any details about studies, acceptance criteria, sample sizes, ground truth, or expert qualifications.

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