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    K Number
    K082195
    Device Name
    MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
    Manufacturer
    DEPUY SPINE, INC.
    Date Cleared
    2008-09-03

    (30 days)

    Product Code
    NKB,KWP,KWQ,MNH,MNI
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K073126,K011182
    Why did this record match?
    Device Name :

    MODIFICATIONS TO EXPEDIUM SPINE SYSTEM

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

    The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

    The EXPEDIUM™ Spine 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

    The subject EXPEDIUM Spine System components consist of designs that interface to 5.5mm and 6.35mm rods and are available in various geometries and sizes.
    Materials: Manufactured from ASTM F 138 implant grade stainless steel and ASTM F 136 implant grade titanium alloy.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the EXPEDIUM Spine System, a medical device for spinal fixation. It details the device's classification, intended use, and indicates that performance data based on ASTM F 1717 were submitted.

    However, the provided document does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or any of the detailed aspects of a performance study as requested in the prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance).

    The relevant section only states:

    • Performance Data: "Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification."

    Therefore, I cannot provide the requested information about acceptance criteria, study details, and performance metrics based on the input provided. The document focuses on the regulatory submission process and the device's intended use and materials, not on a detailed clinical or technical performance study report.

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