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

    NEXTGEN ALTIUS OCT SYSTEM

    K Number: K113593 · Decision Apr 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    13
    Review Days
    134

    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
    NEXTGEN ALTIUS OCT SYSTEM
    K Number
    K113593
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Spine (Aka Ebi, LLC)
    Date Received
    December 5, 2011
    Decision Date
    April 17, 2012
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

    Similar 510(k) Clearances

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

    LnK Posterior Cervical Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OASYS System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sure Lok Mini Posterior Cervical/Upper Thoracic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Reliance Posterior Cervical-Thoracic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Streamline OCT Occipito-Cervico-Thoracic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLSTICE OCT System

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

    Other Clearances by Biomet Spine (Aka Ebi, LLC)

    K Number Device Name
    K133518 MAXAN ANTERIOR CERVICAL PLATE SYSTEM
    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
    K110650 ZYSTON ARC INTERBODY SPACER
    Search all 13 clearances from Biomet Spine (Aka Ebi, LLC) →