BEUDAMED
    Product Code: HXY FDA class 1 21 CFR 888.4540

    Brace, Drill

    Orthopedic

    A drill brace is a handheld device used to hold and guide a drill bit during orthopedic bone drilling procedures, providing the operator with a stable grip and directional control for accurate hole placement. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk subject to general controls. Product code HXY falls under the Orthopedic medical specialty.

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    510(k)s
    7
    FEI Numbers
    92
    Registration Numbers
    92
    Unique Applicants
    6
    Years Active
    16

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    Basic Information

    Product Code
    HXY
    Device Class
    FDA class 1
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K923776 BENDEREV DRILL GUIDE
    K892904 MITEK DRILL GUIDE
    K880264 BONE SUTURE FIXATION DEVICE
    K880381 TELOS DISTAL TARGETING DEVICE
    K880046 HASTING FINGER FIXATOR INSTRUMENTS
    K831043 ANDREWS REMOTE CHUCK DRILL
    K770204 CEMENT EXTRACTOR DRILL

    FEI Numbers

    This FDA classification entry is associated with 92 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 92 registration numbers. Click on an entry to view related FDA registrations.