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510(k) Data Aggregation

    K Number
    K252696

    Validate with FDA (Live)

    Device Name
    LEGACY
    Manufacturer
    Phasor Health, LLC
    Date Cleared
    2025-11-21

    (86 days)

    Product Code
    HBG
    Regulation Number
    882.4300
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K961113,K161704
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Phasor LEGACY drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.

    Device Description

    Phasor LEGACY drill is indicated for drilling of cranial bone by licensed and credentialed medical professionals. The LEGACY drill is manually powered by rotating the handle in a clockwise manner, and is a standalone drill driver without bits or any other items included. It is compatible via an AO quick-connect mechanism with similar AO-interface drill bits, ≤ 6.35 mm diameter and ≤ 70 mm usable length (protruding from the housing). The device is gamma-sterilized and composed of plastic housing with stainless steel shaft.

    AI/ML Overview

    N/A

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