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    K Number
    K061577
    Device Name
    OVALTWIST PEDICLE SCREW SYSTEM
    Manufacturer
    SIGNUS MEDIZINTECHNIK GMBH
    Date Cleared
    2006-09-14

    (99 days)

    Product Code
    MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OVALTWIST PEDICLE SCREW SYSTEM

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

    The OvalTwist System is intended for posterior, non-cervical pedicle fixation for the following indications: • Spondylolisthesis · Trauma (i.e., fracture or dislocation) • Spinal stenosis · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) • Tumor • Pseudoarthrosis • Failed previous fusion

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the OvalTwist Pedicle Screw System. This document is a regulatory approval for a medical device and does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

    Therefore, I cannot provide the requested information. The document focuses on confirming that the device is substantially equivalent to a legally marketed predicate device, outlines regulatory compliance requirements, and lists the indications for use. It does not describe performance metrics, clinical study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of a device as if it were a diagnostic or AI-driven system.

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