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

    Blue Topaz Sacroiliac Screw System

    K Number: K213590 · Decision Mar 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    130
    Applicant Total
    5
    Review Days
    109

    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
    Blue Topaz Sacroiliac Screw System
    K Number
    K213590
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osseus Fusion Systems, LLC
    Date Received
    November 12, 2021
    Decision Date
    March 1, 2022
    Product Code
    OUR
    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
    OUR Sacroiliac Joint Fixation

    Similar 510(k) Clearances

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

    CATAMARAN™ SI Joint Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    iFuse INTRA Ti™ Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Falco Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sacroiliac Joint Truss System (SJTS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OptumSI Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SIros-X System

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

    Other Clearances by Osseus Fusion Systems, LLC

    K Number Device Name
    K181347 Aries® Lumbar Interbodies
    K170844 Gemini-C Hybrid Cervical Interbody System
    K160522 White Pearl Preferred Angle Anterior Cervical Plate
    K131810 OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM