BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    CastleLoc Pectus Bar System

    K Number: K260448 · Decision Mar 19, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    57
    Review Days
    36

    Basic Information

    Device Name
    CastleLoc Pectus Bar System
    K Number
    K260448
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    L&K BIOMED Co., Ltd.
    Date Received
    February 11, 2026
    Decision Date
    March 19, 2026
    Product Code
    HRS
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HRS Plate, Fixation, Bone

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    Other Clearances by L&K BIOMED Co., Ltd.

    K Number Device Name
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