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

    GENESYS SPINE TILOCK SYSTEM

    K Number: K103671 · Decision Jul 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    31
    Review Days
    217

    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
    GENESYS SPINE TILOCK SYSTEM
    K Number
    K103671
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genesys Spine
    Date Received
    December 16, 2010
    Decision Date
    July 21, 2011
    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 Genesys Spine

    K Number Device Name
    K252322 SIros-X System
    K242483 Genesys Spine AIS-C II Cervical Interbody Fusion System
    K233595 Genesys Spine Sacroiliac Joint Fusion System with Navigation
    K233594 Genesys Spine 3DP AIS-C II Cervical Interbody System
    K220096 Genesys Spine 3DP Lumbar Interbody System
    K191489 Genesys Spine 3DP Cervical Interbody System
    K182987 Genesys Spine 3DP Lumbar Interbody System
    K192678 Genesys Spine Binary® Lumbar Plate System
    K191748 Genesys Spine Sacroiliac Joint Fusion System
    K192076 Binary® Anterior Cervical Plate System
    Search all 31 clearances from Genesys Spine →