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

    4CIS® Chiron Spinal Fixation System

    K Number: K231655 · Decision Nov 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    17
    Review Days
    539

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    Basic Information

    Device Name
    4CIS® Chiron Spinal Fixation System
    K Number
    K231655
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Solco Biomedical Co., Ltd.
    Date Received
    June 6, 2023
    Decision Date
    November 26, 2024
    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

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    Other Clearances by Solco Biomedical Co., Ltd.

    K Number Device Name
    K203233 4CIS Chiron Spinal Fixation System
    K192044 4CIS Marlin PEEK ACIF Cage
    K190563 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage
    K190471 4CIS® Chiron Spinal Fixation System
    K182489 4CIS® Pinehurst Anterior Cervical Plate system
    K162402 4CIS® Marlin ACIF Cage System
    K121615 4CIS VANE SPINE SYSTEM
    K102458 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
    K101818 4CIS VANE SPINE SYSTEM
    K092162 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
    Search all 17 clearances from Solco Biomedical Co., Ltd. →