BEUDAMED
    Product Code: HWX FDA class 1 21 CFR 888.4540

    Tap, Bone

    Orthopedic

    A bone tap is a threaded orthopedic instrument used to cut internal threads in a pre-drilled bone hole, allowing bone screws to be inserted with proper purchase and reducing the risk of bone fracture during screw placement. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk and general controls only. Product code HWX falls under the Orthopedic medical specialty.

    View on FDA
    510(k)s
    2
    FEI Numbers
    304
    Registration Numbers
    304
    Unique Applicants
    2
    Years Active
    3

    Research product code HWX in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    HWX
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K873067 ACROMED BONE SCREW TAP SLEEVES
    K840735 FEMORAL CEMENT REMOVAL INSTRUMENT

    FEI Numbers

    This FDA classification entry is associated with 304 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 304 registration numbers. Click on an entry to view related FDA registrations.