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510(k) Data Aggregation

    K Number
    K061520

    Validate with FDA (Live)

    Device Name
    VIPER SPINE SYSTEM
    Manufacturer
    DEPUY SPINE, INC.
    Date Cleared
    2006-06-23

    (21 days)

    Product Code
    NKB,KWP,KWQ,MNH,MNI
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K041801
    Predicate For
    K061813,K062670,K070387,K071860,K081978,K090648,K100605,K101112,K110896,K112037,K120696,K121728,K131810,K133575,K160124,K160926
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VIPER 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.

    When used in a percutaneous, posterior approach with MIS instrumentation, the VIPER 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 VIPER Spine System consists of cannulated polyaxial pedicle screws and 5.5mm rods in various lengths. The VIPER Spine System also contains Class 1 manual surgical instruments to aid in the percutaneous approach, and cases that are considered exempt from premarket notification. Manufactured from ASTM F-136 implant grade titanium alloy.

    AI/ML Overview

    The provided text is for a 510(k) premarket notification for a medical device called the VIPER™ Spine System. This is a mechanical device (spinal fixation system), not an AI/Software as a Medical Device (SaMD).

    Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and training set details, which are typically relevant for AI/SaMD, is not applicable to this document.

    The "Performance Data" section in the K061520 submission simply states: "Performance data were submitted to characterize the cannulated polyaxial screws." This indicates that some form of engineering or mechanical testing was conducted to ensure the device's physical properties and functionality met relevant standards (e.g., strength, fatigue, biocompatibility), but the specific criteria and results are not detailed in this summary.

    In summary, none of the requested information regarding AI/SaMD performance criteria and study details can be extracted from this document because it describes a hardware medical device lacking an AI component.

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