BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System

    K Number: K203129 · Decision Jan 12, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    161
    Applicant Total
    24
    Review Days
    85

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    Basic Information

    Device Name
    NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
    K Number
    K203129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Precision Spine, Inc.
    Date Received
    October 19, 2020
    Decision Date
    January 12, 2021
    Product Code
    OVE
    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
    OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

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