BEUDAMED
    Product Code: KIL FDA class 1 21 CFR 888.4540

    Positioner, Socket

    Orthopedic

    Socket Positioner is a surgical tool used in orthopedic joint replacement procedures to properly orient and seat the acetabular or other socket component of a prosthetic joint implant, ensuring accurate cup placement and alignment during total joint arthroplasty. 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 KIL, regulated under 21 CFR 888.4540, within the Orthopedic medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    KIL
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K932187 PRONE POSITIONER

    FEI Numbers

    This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.