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510(k) Data Aggregation

    K Number
    K033901
    Device Name
    MERLIN SPINE SYSTEM
    Manufacturer
    DEPUY SPINE,INC
    Date Cleared
    2004-03-31

    (105 days)

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

    MERLIN SPINE SYSTEM

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

    The Merlin Spinal System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for the Merlin Spine System and does not contain information about acceptance criteria or a study proving the device meets them. The document outlines the regulatory approval of the device based on substantial equivalence to predicate devices, but it does not include details on performance metrics, study design, sample sizes, expert qualifications, or ground truth establishment relevant to the questions you've asked regarding device performance and acceptance criteria.

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