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

    Facet-Link Stabilization Platform

    K Number: K150223 · Decision Apr 28, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    77
    Applicant Total
    2
    Review Days
    88

    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
    Facet-Link Stabilization Platform
    K Number
    K150223
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Facet-Link, Inc.
    Date Received
    January 30, 2015
    Decision Date
    April 28, 2015
    Product Code
    MRW
    Advisory Committee
    Unknown
    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
    MRW System, Facet Screw Spinal Device

    Similar 510(k) Clearances

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

    Ion-L

    FDA 510(k)
    FDA Unclassified ·Unknown

    CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)

    FDA 510(k)
    FDA Unclassified ·Unknown

    DiversiVy™ Facet Screw System

    FDA 510(k)
    FDA Unclassified ·Unknown

    Ion-C

    FDA 510(k)
    FDA Unclassified ·Unknown

    FFX Facet Fixation System

    FDA 510(k)
    FDA Unclassified ·Unknown

    CORUS-LX Implant

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Facet-Link, Inc.

    K Number Device Name
    K123497 FACET SCREW SYSTEM