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510(k) Data Aggregation

    K Number
    K062270
    Device Name
    RADIUS SPINAL SYSTEM
    Manufacturer
    STRYKER SPINE
    Date Cleared
    2006-11-22

    (107 days)

    Product Code
    NKB,KWP,KWQ,MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K042270
    Predicate For
    K070631,K071373,K082608,K083393,K091291,K101144,K133188
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Radius™ Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (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; pseudoarthrosis; and failed previous fusion.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for the Stryker Spine Radius™ Spinal System. It does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria. This document primarily focuses on the regulatory clearance for marketing the device based on substantial equivalence to predicate devices, rather than a detailed performance study.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth, or MRMC comparative effectiveness studies from this text.

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