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

    NFIX II PEDICLE SCREW SYSTEM

    K Number: K061774 · Decision Dec 13, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    173

    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
    NFIX II PEDICLE SCREW SYSTEM
    K Number
    K061774
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    N Spine, Inc.
    Date Received
    June 23, 2006
    Decision Date
    December 13, 2006
    Product Code
    NQP
    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
    NQP Posterior Metal/Polymer Spinal System, Fusion

    Similar 510(k) Clearances

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

    CD HORIZON™ Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD Horizon™ Astute™ Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD Horizon™ Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DYNESYS TOP-LOADING SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZIMMER DTO PIN PRESS INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DSS STABILIZATION SYSTEM

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

    Other Clearances by N Spine, Inc.

    K Number Device Name
    K072685 NGARDE SYSTEM