BEUDAMED
    Product Code: HTT FDA class 1 21 CFR 888.4540

    Burr, Orthopedic

    Orthopedic

    An orthopedic burr is a small, rotating cutting instrument used to grind, shape, or remove bone material during orthopedic surgical procedures, typically attached to a power drill or handpiece. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk and general controls only. Product code HTT falls under the Orthopedic medical specialty.

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    510(k)s
    4
    FEI Numbers
    95
    Registration Numbers
    95
    Unique Applicants
    4
    Years Active
    10

    Basic Information

    Product Code
    HTT
    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 4 510(k) clearances via K numbers.

    K Number Device Name
    K862529 HALL STERILE BUR
    K821695 MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER
    K802598 CARBIDE CUTTING INSTRUMENT/INTRAARTICU
    K760236 BUR, SURGICAL CARBIDE

    FEI Numbers

    This FDA classification entry is associated with 95 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 95 registration numbers. Click on an entry to view related FDA registrations.