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

    MAXAN ANTERIOR CERVICAL PLATE SYSTEM

    K Number: K133518 · Decision Nov 5, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    13
    Review Days
    355

    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
    MAXAN ANTERIOR CERVICAL PLATE SYSTEM
    K Number
    K133518
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Spine (Aka Ebi, LLC)
    Date Received
    November 15, 2013
    Decision Date
    November 5, 2014
    Product Code
    KWQ
    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
    KWQ Appliance, Fixation, Spinal Intervertebral Body

    Similar 510(k) Clearances

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

    ARIES Anterior Cervical Plate Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CastleLoc-P Anterior Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    corra™ cervical plating system

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VyPlate™ Anterior Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANTERIS Thoracolumbar Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PathLoc Lumbar Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Biomet Spine (Aka Ebi, LLC)

    K Number Device Name
    K140710 BIOMET GRAFT DELIVERY SYRINGES
    K132373 BIOMET ACCESS SYSTEM
    K133746 POLARIS SPINAL SYSTEM
    K131615 POLARIS SPINAL SYSTEM
    K123549 POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
    K123451 POLARIS SPINAL SYSTEM - BALLISTA II RODS
    K122989 BIOMET LATERAL SPACER SYSTEM
    K122378 NEXTGEN ALTIUS OCT SYSTEM
    K113593 NEXTGEN ALTIUS OCT SYSTEM
    K110650 ZYSTON ARC INTERBODY SPACER
    Search all 13 clearances from Biomet Spine (Aka Ebi, LLC) →