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510(k) Data Aggregation

    K Number
    K012817
    Device Name
    HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED
    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, NON-CANNULATED

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

    This device is used in general management of fractures and reconstructive surgery.

    Device Description

    Not Found

    AI/ML Overview

    Since the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Triage Medical, Inc. Helical Compression Anchor), it does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth.

    This document is a regulatory clearance letter, confirming that the device is substantially equivalent to a predicate device and can be marketed. It does not provide the technical details of any performance studies that would have been submitted to support this claim.

    To answer your request, I would need access to the actual 510(k) submission or a summary thereof, which typically includes the performance data and methodology.

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