BEUDAMED
    Product Code: HWL FDA class 1 21 CFR 888.4540

    Set, Hollow Mill

    Orthopedic

    A hollow mill set is a set of cylindrical cutting tools used in orthopedic surgery to remove bone around a pin or implant, or to cut a precise cylindrical channel in bone for prosthetic components. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HWL falls under the Orthopedic medical specialty.

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    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HWL
    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

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.