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510(k) Data Aggregation

    K Number
    K150673
    Device Name
    SYNFIX Evolution Secured Spacer System
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Date Cleared
    2015-08-21

    (158 days)

    Product Code
    OVD
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K072253,K072981,K122639,K131276,K121982,K141942
    Predicate For
    K162358,K180002,K180695,K201585,K250072
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SYNFIX Evolution Secured System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the interior of the spacer component of the SYNFIX Evolution can be packed with autograft.

    DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

    Device Description

    The SYNFIX Evolution Secured Spacer System is a combination radiolucent and radiopaque intervertebral body fusion device. Four screws are inserted through the anteriorly-located plate into the adjacent vertebral bodies. The screws lock securely to the plate using a tapered-thread locking mechanism. The SYNFIX Evolution Secured Spacer System is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.

    AI/ML Overview

    The provided text is a 510(k) summary for the SYNFIX® Evolution Secured Spacer System and does not contain information about an AI-powered medical device or studies related to AI performance. Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI device.

    The document discusses a traditional medical device, an intervertebral body fusion device, and its substantial equivalence to predicate devices based on mechanical testing and Finite Element Analysis. There is no mention of AI, machine learning, or algorithms.

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