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

    Wiltrom Spinal Fixation System

    K Number: K202894 · Decision Oct 23, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    5
    Review Days
    25

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    Basic Information

    Device Name
    Wiltrom Spinal Fixation System
    K Number
    K202894
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wiltrom Corporation Limited
    Date Received
    September 28, 2020
    Decision Date
    October 23, 2020
    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 Wiltrom Corporation Limited

    K Number Device Name
    K180758 Osteocera Resorbable Bone Substitute
    K172237 Bicera Resorbable Bone Substitute
    K172548 Wiltrom Spinal Fixation System
    K110949 BICERA (TM) RESORBABLE BONE SUBSTITUTE