BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    TREND II Spinal Fixation System- STEP Series

    K Number: K180226 · Decision Jul 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    6
    Review Days
    180

    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
    TREND II Spinal Fixation System- STEP Series
    K Number
    K180226
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paonan Biotech Co., Ltd.
    Date Received
    January 26, 2018
    Decision Date
    July 25, 2018
    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 Paonan Biotech Co., Ltd.

    K Number Device Name
    K220261 NEST-C Interbody System
    K182285 PK High Tibial Osteotomy Correction System
    K180230 NEST Interbody System
    K180228 II-Type Intervertebral Spacer
    K161225 Paonan Armstrong Posterior Spinal Fixation System