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

    CastleLoc-S Posterior Cervical Fixation System

    K Number: K231840 · Decision Jul 20, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    117
    Applicant Total
    57
    Review Days
    28

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    Basic Information

    Device Name
    CastleLoc-S Posterior Cervical Fixation System
    K Number
    K231840
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3075
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    L&K BIOMED Co., Ltd.
    Date Received
    June 22, 2023
    Decision Date
    July 20, 2023
    Product Code
    NKG
    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
    NKG Posterior Cervical Screw System

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

    K Number Device Name
    K260840 BluEX Cervical Expandable Cage System
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    K260448 CastleLoc Pectus Bar System
    K251940 PathLoc Lumbar Plate System
    K251741 PathLoc Lumbar Interbody Fusion Cage System
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    K243357 CastleLoc Pectus Bar System
    K242829 BluEX Lumbar Expandable Cage System
    K240201 PathLoc SI Joint Fusion System
    Search all 57 clearances from L&K BIOMED Co., Ltd. →