BEUDAMED
    Product Code: HTQ FDA class 1 21 CFR 888.4540

    Broach

    Orthopedic

    An orthopedic broach is a cutting instrument used during joint replacement surgery to shape and prepare the medullary canal or bone cavity to receive an implant, particularly femoral stems and tibial trays. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HTQ falls under the Orthopedic medical specialty.

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    510(k)s
    0
    FEI Numbers
    125
    Registration Numbers
    125
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HTQ
    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 125 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 125 registration numbers. Click on an entry to view related FDA registrations.