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

    LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System

    K Number: K200793 · Decision Oct 8, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    117
    Applicant Total
    57
    Review Days
    196

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    Basic Information

    Device Name
    LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System
    K Number
    K200793
    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
    March 26, 2020
    Decision Date
    October 8, 2020
    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
    K261112 CastleLoc-P Anterior Cervical Plate System
    K261130 AccelFix Spinal Fixation System
    K260448 CastleLoc Pectus Bar System
    K251940 PathLoc Lumbar Plate System
    K251741 PathLoc Lumbar Interbody Fusion Cage System
    K250892 CastleLoc Pectus Bar System
    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. →