BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)

    K Number: K072961 · Decision Dec 19, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    37
    Same Product Code
    22
    Applicant Total
    5
    Review Days
    61

    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
    LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)
    K Number
    K072961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.4580
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sra Developments, Ltd.
    Date Received
    October 19, 2007
    Decision Date
    December 19, 2007
    Product Code
    JDX
    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
    JDX Instrument, Surgical, Sonic And Accessory/Attachment

    Similar 510(k) Clearances

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

    Ultrasonic Osteotomy Surgical System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XD880A Ultrasonic Osteotomy Surgical System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIEZOTOME M+, PIEZOTOME M+ Handpiece

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIEZOSURGERY PLUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIEZOSURGERY FLEX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIEZOELECTRIC SYSTEM

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

    Other Clearances by Sra Developments, Ltd.

    K Number Device Name
    K221102 LOTUS Series 4 Enhanced Shears, LOTUS Series 5
    K151101 Lotus Series 4 Ultrasonic Surgical System & Accessories
    K063531 SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM
    K032424 LOTUS