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

    LDR SPINE EASYSPINE SYSTEM

    K Number: K082592 · Decision Oct 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    25
    Review Days
    30

    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
    LDR SPINE EASYSPINE SYSTEM
    K Number
    K082592
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ldr Spine USA
    Date Received
    September 8, 2008
    Decision Date
    October 8, 2008
    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 Ldr Spine USA

    K Number Device Name
    K153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
    K152137 FacetBRIDGE System
    K151934 ROI-C Titanium-Coated Implant System
    K150765 LDR Spine ROI-C Cervical Cage System
    K110327 LDR SPINE ROI-A INTERBODY FUSION SYSTEM
    K102331 LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
    K102265 LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM
    K100575 LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
    K091088 LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
    K090507 MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM
    Search all 25 clearances from Ldr Spine USA →