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

    NuVasive Sterilization Trays

    K Number: K143579 · Decision Aug 28, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    112
    Review Days
    253

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NuVasive Sterilization Trays
    K Number
    K143579
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nu Vasive, Incorporated
    Date Received
    December 18, 2014
    Decision Date
    August 28, 2015
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KCT), ordered by most recent decision date.

    SteriBest® Sterilization Tray System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SteriTite Container System with MediTray Products

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Straumann® ProClean™ Cassette (041.800 ; 041.801)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Stainless Steel Surgical Kits

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterilization Trays

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    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
    K223181 NuVasive Reline System
    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
    Search all 112 clearances from Nu Vasive, Incorporated →