LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K214059
    Device Name
    CoreLink Navigation Instruments
    Manufacturer
    CoreLink, LLC
    Date Cleared
    2022-01-19

    (23 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K200863,K212825,K181111
    Why did this record match?
    Reference Devices :

    K200863

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

    CoreLink Navigation Instruments are intended to be used in the preparation and placement of Tiger OCT screw implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System S8 (V1.2.20), which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    Device Description

    CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.

    The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer compatibility with CoreLink OCT pedicle screws.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for "CoreLink Navigation Instruments." This submission does not relate to an AI/ML powered device, but rather to traditional surgical navigation instruments. Therefore, the information requested in the prompt regarding acceptance criteria and studies for an AI/ML device cannot be extracted from the provided text.

    The text focuses on demonstrating substantial equivalence to a predicate device for the purpose of adding new instruments to an existing navigation system. The performance data mentioned specifically refers to "confirmatory positional accuracy testing per ASTM F2554" and "engineering analysis including tolerance stack analysis," which are standard for mechanical medical devices, not AI/ML algorithms.

    Therefore, I cannot fulfill the request as the provided document does not contain information about an AI/ML powered device or its associated acceptance criteria and validation studies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1