BEUDAMED
    Product Code: HWD FDA class 1 21 CFR 888.4540

    Starter, Bone Screw

    Orthopedic

    A bone screw starter is a handheld orthopedic instrument used to create an initial pilot point or guide in bone, facilitating the accurate insertion of bone screws and preventing screw slippage during placement. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk and general controls only. Product code HWD falls under the Orthopedic medical specialty.

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    510(k)s
    0
    FEI Numbers
    96
    Registration Numbers
    96
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    HWD
    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 96 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 96 registration numbers. Click on an entry to view related FDA registrations.