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510(k) Data Aggregation

    K Number
    K240423
    Device Name
    TDM Anterior Cervical Plate System
    Manufacturer
    TDM Co., Ltd.
    Date Cleared
    2024-04-08

    (55 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K171808,K190391,K000742
    Why did this record match?
    Device Name :

    TDM Anterior Cervical Plate System

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

    The TDM Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to C7). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment ve disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

    Device Description

    The TDM Anterior Cervical Plate System consists of cervical plates, screws and the instruments necessary to implant this specific system. All implant components are made from a titanium alloy (Ti-6AL-4V). The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and self-drilling bone screws using an anterior approach. Cervical Plate System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria.

    The document is a 510(k) premarket notification clearance letter from the FDA for the "TDM Anterior Cervical Plate System." It confirms that the device is substantially equivalent to a legally marketed predicate device.

    The section titled "Performance Data" mentions:

    • Non-clinical testing: static compression, dynamic compression, and static torsion.
    • Standard: ASTM F1717.
    • Purpose: to demonstrate substantial equivalence to the predicate device.

    However, it does not provide specific acceptance criteria values for these tests, nor does it list detailed results or a study report with sample sizes, data provenance, ground truth establishment, or any of the other specific information requested in your prompt regarding acceptance criteria and a study proving their fulfillment. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with explicit acceptance criteria.

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