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510(k) Data Aggregation

    K Number
    K062174
    Device Name
    MODIFICATION TO EXPEDIUM SPINE SYSTEM
    Manufacturer
    DEPUY SPINE, INC.
    Date Cleared
    2006-11-02

    (94 days)

    Product Code
    MNH,KWP,KWQ,MNI,NKB
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K051024,K052131,K041119,K033901,K021148,K010576,K041203,K944756
    Predicate For
    K063156,K063741,K063772,K070387,K073562,K080313,K090799,K092626,K101070,K102204,K102249,K103133,K110216,K112920,K113396,K130877,K133369,K133575,K160124
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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

    EXPEDIUM Spine System components are designed to accept a 6.35mm rod and are available in various qeometries and sizes.

    The EXPEDIUM Spine System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device, the EXPEDIUM Spine System. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, and therefore, it is not possible to fill out the requested table or answer the specific questions.

    The document primarily focuses on:

    • Device Description: What the EXPEDIUM Spine System is (components, materials).
    • Intended Use/Indications: What the device is designed to treat.
    • Predicate Devices: Other similar devices already on the market.
    • Regulatory Information: The FDA's review and determination of substantial equivalence to existing devices.

    The section titled "PERFORMANCE DATA:" merely states "Performance data were submitted to characterize the EXPEDIUM Spine System components subject of this notification." It does not provide any details about the nature of this performance data, any specific acceptance criteria, or the results of any studies.

    Therefore, the requested information cannot be extracted from the provided text.

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