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510(k) Data Aggregation

    K Number
    K242869
    Device Name
    prodisc® L Instruments
    Manufacturer
    Centinel Spine LLC
    Date Cleared
    2024-12-17

    (88 days)

    Product Code
    QLQ
    Regulation Number
    888.4515
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K221848
    Predicate For
    K250554
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.

    Device Description

    The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® L Instruments.

    AI/ML Overview

    This document is a 510(k) premarket notification for the prodisc® L Instruments. It does not present a study or acceptance criteria for device performance related to diagnostic accuracy or AI/algorithm performance.

    Instead, this document is a regulatory submission demonstrating the substantial equivalence of surgical instruments (prodisc® L Instruments) to previously cleared predicate devices. The focus is on the instruments' design, materials, manufacturing, and intended use for placing, positioning, and removing prodisc® L implants.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the content of this 510(k) summary for surgical instruments.

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