BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Facilis™ Spinal System

    K Number: K161231 · Decision Jan 23, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    5
    Review Days
    266

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    Basic Information

    Device Name
    Facilis™ Spinal System
    K Number
    K161231
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baui Biotech Co., Ltd.
    Date Received
    May 2, 2016
    Decision Date
    January 23, 2017
    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 Baui Biotech Co., Ltd.

    K Number Device Name
    K242899 NOVA Minimally Invasive System
    K191353 COMET Lumbar Interbody Fusion Cage
    K191494 Facilis™ Spinal System
    K182416 NOVA Minimally Invasive System