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510(k) Data Aggregation

    K Number
    K062992
    Device Name
    SPINAL SPHERES
    Manufacturer
    INTERBODY INNOVATIONS LLP
    Date Cleared
    2007-07-27

    (298 days)

    Product Code
    NVR
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K051320
    Predicate For
    K073105
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spinal Spheres are intended to be inserted between vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Spheres are intended to be used with bone graft.

    Device Description

    The Spinal Spheres consist of CoCtMo spheres which may be implanted from L3 to S1 to 16 morary stabilization in order to promote fusion. These spheres are available in Ø10-Ø16mm diameters.

    AI/ML Overview

    This document is a 510(k) summary for the Spinal Spheres device, which is an orthopedic implant for intervertebral fusion. As such, it does not describe acceptance criteria, a study proving device performance, or information related to AI/algorithm performance. The provided text is a regulatory submission for a medical device and does not contain the requested information regarding AI device evaluation.

    Therefore, I cannot fulfill your request as the provided input does not describe an AI medical device or its evaluation.

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