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510(k) Data Aggregation

    K Number
    K091118
    Device Name
    FOOT AND HAND MOTION SYSTEM
    Manufacturer
    NEWCLIP TECHNICS
    Date Cleared
    2009-12-16

    (243 days)

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

    FOOT AND HAND MOTION SYSTEM

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

    The implants of the Foot and Hand Motion System are indicated for the fixation of bone fractures and for bone reconstruction in the hand and forefoot surgery.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the "Newclip Foot and Hand Motion System". It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

    The request asks for specific details about these aspects, but they are not present in the given FDA letter. This type of document typically confirms regulatory clearance based on substantial equivalence to existing devices, and often refers to supporting data supplied by the manufacturer in their 510(k) submission, rather than detailing the studies themselves within the clearance letter.

    Therefore, I cannot provide the requested information from the given text.

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