BEUDAMED
    Product Code: KIK FDA class 1 21 CFR 878.4800

    Hook, Bone

    General, Plastic Surgery

    Bone Hook is a manual surgical instrument with a curved or hooked end used in orthopedic and general surgical procedures to retract, manipulate, or reposition bone fragments or skeletal structures during open surgical access, providing the surgeon with mechanical advantage and controlled bone handling. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIK, regulated under 21 CFR 878.4800, within the General, Plastic Surgery medical specialty.

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    510(k)s
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    KIK
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K770759 HOOK HOLLER

    FEI Numbers

    This FDA classification entry is associated with 119 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 119 registration numbers. Click on an entry to view related FDA registrations.