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

    STALIF X

    K Number: K130461 · Decision Aug 28, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    254
    Registration Numbers
    254
    Same Product Code
    194
    Applicant Total
    1
    Review Days
    187

    Basic Information

    Device Name
    STALIF X
    K Number
    K130461
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CENTINEL SPINE INC.
    Date Received
    February 22, 2013
    Decision Date
    August 28, 2013
    Product Code
    OVD
    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
    OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

    Similar 510(k) Clearances

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

    CONDUIT™ SYNFIX™ Evolution Secured Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ProAM ALIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Curiteva Porous PEEK Standalone ALIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OneLIF™ Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Stable-L Lumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ventris Intervertebral Body Fusion Device

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