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

    AFFIX II SPINOUS PROCESS PLATE SYSTEM

    K Number: K132411 · Decision Nov 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    47
    Applicant Total
    112
    Review Days
    110

    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
    AFFIX II SPINOUS PROCESS PLATE SYSTEM
    K Number
    K132411
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nu Vasive, Incorporated
    Date Received
    August 2, 2013
    Decision Date
    November 20, 2013
    Product Code
    PEK
    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
    PEK Spinous Process Plate

    Similar 510(k) Clearances

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

    Minuteman® G6 MIS Fusion Plate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KeyLift™ Expandable Interlaminar Stabilization System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    primaLOK™ SP Interspinous Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Huvex Interspinous Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    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 →