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

    LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.

    K Number: K231636 · Decision Jun 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    57
    Review Days
    22

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
    K Number
    K231636
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    L&K BIOMED Co., Ltd.
    Date Received
    June 5, 2023
    Decision Date
    June 27, 2023
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NKB), ordered by most recent decision date.

    “Socko” Vimax Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ChanPin Pedicle Screw Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Varion Thoracolumbar Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AccelFix Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERLA® TL Posterior Thoraco-lumbar Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    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. →