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

    NuVasive Reline System

    K Number: K223181 · Decision Jan 11, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    112
    Review Days
    92

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    Basic Information

    Device Name
    NuVasive Reline System
    K Number
    K223181
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nu Vasive, Incorporated
    Date Received
    October 11, 2022
    Decision Date
    January 11, 2023
    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 Nu Vasive, Incorporated

    K Number Device Name
    K231735 NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System
    K230894 NuVasive Modulus ALIF System
    K230989 Rod Registration Frame
    K221751 NuVasive Cohere ALIF System Intervertebral Body Fusion Device
    K221388 NuVasive Reline Cervical System
    K220478 NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System
    K213654 NuVasive Reline Cervical System
    K203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty
    K212446 NuVasive Anterior Cervical Plate Systems
    K210574 NuVasive Pulse System
    Search all 112 clearances from Nu Vasive, Incorporated →