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

    4CIS® Marlin ACIF Cage System

    K Number: K162402 · Decision Feb 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    348
    Applicant Total
    17
    Review Days
    174

    Basic Information

    Device Name
    4CIS® Marlin ACIF Cage System
    K Number
    K162402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Solco Biomedical Co., Ltd.
    Date Received
    August 26, 2016
    Decision Date
    February 16, 2017
    Product Code
    ODP
    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
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

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    Other Clearances by Solco Biomedical Co., Ltd.

    K Number Device Name
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    K182489 4CIS® Pinehurst Anterior Cervical Plate system
    K121615 4CIS VANE SPINE SYSTEM
    K102458 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
    K101818 4CIS VANE SPINE SYSTEM
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