BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    TriALTIS™ Spine System

    K Number: K233684 · Decision Dec 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    96
    Review Days
    26

    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
    TriALTIS™ Spine System
    K Number
    K233684
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medos International SARL
    Date Received
    November 16, 2023
    Decision Date
    December 12, 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

    Similar 510(k) Clearances

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

    “Socko” Vimax Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ChanPin Pedicle Screw Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Varion Thoracolumbar Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AccelFix Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERLA® TL Posterior Thoraco-lumbar Fixation System

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

    Other Clearances by Medos International SARL

    K Number Device Name
    K254157 CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
    K260240 SYMPHONY Navigation Ready Instruments
    K253249 TriALTIS™ Spine System
    K243249 TriALTIS™ Spine System
    K241893 CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays
    K242042 TriALTIS™ Spine System
    K233366 SYMPHONY OCT System
    K232492 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor
    K231479 TriALTIS Spine System
    K223438 TELIGEN System Peripheral Motor Nerve Stimulation Indications
    Search all 96 clearances from Medos International SARL →