LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K171832
    Device Name
    Range/Denali/Mesa Spinal System
    Manufacturer
    K2M, Inc.
    Date Cleared
    2017-09-14

    (86 days)

    Product Code
    NKB,KWP,KWQ
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K141873,K070229,K120099,K121630,K140765,K083810
    Predicate For
    K171556,K180376,K181119,K181603
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    RANGE /DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical fixation as an adjunct to 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): 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 RANGE Spinal System may also be used for the same indications as an adjunct to fusion.

    Except for the ARI staples, the RANGE Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical fixation in pediatic patients. The RANGE Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

    Device Description

    The Range/Denali/Mesa Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system consisting of pedicle screws, rods, hooks and rod connectors. The purpose of this 510(k) is to add Mesa Hook-Claws to the system.

    Function: The system functions as a spinal fixation device to provide support and stabilization of the posterior thoracic and lumbar spine.

    AI/ML Overview

    This document is a 510(k) premarket notification for the K2M Range/Denali/Mesa Spinal System. It does not describe a study involving a device that uses artificial intelligence or machine learning, therefore, the requested information for acceptance criteria and study details cannot be extracted from the provided text.

    The document discusses a spinal fixation system, its indications for use, comparison to predicate devices, and non-clinical mechanical performance evaluation. It confirms the mechanical testing was performed according to ASTM F1717 standards, which are physical tests, not AI model evaluations.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1