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

    OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM

    K Number: K131810 · Decision Aug 8, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    5
    Review Days
    50

    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
    OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM
    K Number
    K131810
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osseus Fusion Systems, LLC
    Date Received
    June 19, 2013
    Decision Date
    August 8, 2013
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

    Similar 510(k) Clearances

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

    Reliance Spinal Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CastleLoc Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FixxSure® X-Link

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Spinal fixation system

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANAX™ 5.5 Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HC Spinal System

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

    Other Clearances by Osseus Fusion Systems, LLC

    K Number Device Name
    K213590 Blue Topaz Sacroiliac Screw System
    K181347 Aries® Lumbar Interbodies
    K170844 Gemini-C Hybrid Cervical Interbody System
    K160522 White Pearl Preferred Angle Anterior Cervical Plate