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

    MODIFICATION TO STAXX FX SYSTEM

    K Number: K063606 · Decision Apr 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    59
    Review Days
    133

    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
    MODIFICATION TO STAXX FX SYSTEM
    K Number
    K063606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spine Wave, Inc.
    Date Received
    December 1, 2006
    Decision Date
    April 13, 2007
    Product Code
    OBL
    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
    OBL Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty

    Other Clearances by Spine Wave, Inc.

    K Number Device Name
    K260286 Dynamo™ Spinal Cement; Salvo® Spine System
    K261159 Exceed® Biplanar Expandable Interbody System
    K243816 Testa TP Pivoting Spacer System
    K251131 Annex® 2 Adjacent Level System
    K243514 Salvo® Robotic Navigation Instruments
    K240685 Salvo® Spine System
    K231275 Exceed™ Biplanar Expandable Interbody System
    K222362 Salvo® Spine System
    K202476 Salvo® Spine System
    K192526 Spine Wave Navigated Instruments
    Search all 59 clearances from Spine Wave, Inc. →