LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K162321
    Device Name
    EasyClip Xpress
    Manufacturer
    RESTORE SURGICAL LLC dba Instratek
    Date Cleared
    2017-02-10

    (175 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K133523,K122113
    Why did this record match?
    Device Name :

    EasyClip Xpress

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

    The EasyClip XPress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

    Device Description

    EasyClip Xpress is comprised of superelastic bone staples, as well as associated instrumentation required for implantation of the staples.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device called "EasyClip Xpress," which are superelastic bone staples. It describes the device, its intended use, and its equivalence to legally marketed predicate devices. However, it does not contain the detailed information requested regarding acceptance criteria, study methodologies, or performance metrics in the context of an AI/ML device.

    Therefore, I cannot extract the information required by your prompt. This document pertains to a traditional medical device and does not involve AI or algorithms requiring such performance evaluation studies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1