BEUDAMED
    Product Code: HXW FDA class 1 21 CFR 888.4540

    Bender

    Orthopedic

    An orthopedic bender is a handheld instrument used to bend fixation rods, plates, wires, or other metallic hardware to the desired angle or curvature to match patient anatomy during surgical implantation. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk and general controls only. Product code HXW falls under the Orthopedic medical specialty.

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    510(k)s
    3
    FEI Numbers
    220
    Registration Numbers
    220
    Unique Applicants
    3
    Years Active
    1

    Basic Information

    Product Code
    HXW
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K872949 ACROMED BONE PLATE BENDER
    K870668 DRIVER-BENDER-EXTRACTOR, BONE PIN
    K870084 RD 140 SURGICAL BENDER

    FEI Numbers

    This FDA classification entry is associated with 220 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 220 registration numbers. Click on an entry to view related FDA registrations.