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

    Surgify Halo is a sterile surgical burr indicated for shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and general surgical procedures.

    Device Description

    The Surgify Halo is a sterile-packaged, single-use rotary cutting device (a burr) made from high-grade metallic materials, designed to cut bone and other hard tissues selectively while minimizing chattering. The device is similar to conventional surgical cutting burrs but includes a ring mechanism in the burr head to reduce chattering. Like traditional burrs, the device is designed to be compatible with commonly marketed, high-speed, surgical drill systems.

    The Surgify Halo comprises:

    • A head part, which is shaped to have cutting edge(s) to cut hard tissue.
    • Dynamically positioned ring surrounding the burr head that controls the exposure of the cutting edge(s) decreasing chattering and enabling the tissue selective feature.
    • A shaft, which transfers rotary movement from the drill motor to the head.
    • An end-attachment feature, which allows the Surgify Halo to be locked to commonly marketed high-speed, surgical drill systems.
    AI/ML Overview

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