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510(k) Data Aggregation

    K Number
    K151727
    Device Name
    Everest Spinal System
    Manufacturer
    K2M, INC
    Date Cleared
    2015-09-17

    (83 days)

    Product Code
    NKB,KWP,KWQ,MNH,MNI,OSH
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K142360,K081107,K132757,K150325,K143200,K123717
    Why did this record match?
    Reference Devices :

    K142360,K081107,K132757,K150325,K143200,K123717

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

    The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications:

    Posterior non-cervical fixation as an adjunct to fusion 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; pseudarthrosis; and/or failed previous fusion.

    Except for hooks, when used as an anterolateral thoracic/lumbar system the Everest Spinal System may also be used for the same indications as an adjunct to fusion.

    When used for posterior non-cervical pedicle screw fixation in pediatric patients the Everest Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

    Device Description

    The Everest Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The subject 510(k) adds fenestrated cannulated screws to the system.

    Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

    AI/ML Overview

    This document is a 510(k) premarket notification for the Everest Spinal System, which is a medical device. The document does not describe the acceptance criteria of a study or the methods and results of a study designed to prove a device meets acceptance criteria. Instead, it is a submission to the FDA for market clearance, asserting that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) as this document does not contain a description of such a study. It primarily focuses on regulatory classification, device description, indications for use, and a technological comparison to predicate devices, supported by general mechanical testing in accordance with an ASTM standard. No information regarding AI/algorithm performance or ground truth establishment is present.

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