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510(k) Data Aggregation

    K Number
    K091936
    Device Name
    BLADE ANTERIOR CERVICAL PLATE SYSTEM
    Manufacturer
    NEXXT MEDICAL INC
    Date Cleared
    2010-01-19

    (203 days)

    Product Code
    KWQ,KWO
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEXXT MEDICAL INC

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

    The Blade™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the "Blade™ Anterior Cervical Plate System". It determines substantial equivalence to a predicate device and outlines regulatory requirements. It does not contain information about acceptance criteria or performance studies as requested. Therefore, I cannot provide a response to the prompt based on the provided text.

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