LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K041824
    Device Name
    X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
    Manufacturer
    FUTURE MEDICAL SYSTEMS, SA
    Date Cleared
    2005-01-07

    (185 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTURE MEDICAL SYSTEMS, SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeXtra™ arthroscopic pump and shaver system is intended to provide controlled fluid distension and suction, controlled cutting, burring, shaving and abrading of bone and tissue during orthopedic procedures of the knee, shoulder, elbow, wrist, ankle, hip, small joints and temporal mandibular joint (TMJ).
    Device Description
    The NeXtra™ arthroscopic pump and shaver system is a dual pump system that provides inflow and outflow to and from the joint cavities during arthroscopy. It combines a built in shaver that allows the removal of bone and soft tissue during orthopedic procedures. The NeXtra™ console consists of the following components: A power supply, housing, a motherboard, two peristaltic roller heads, three tube rs power supply, nousing, and a touch screen LCD. The system has a user-friendly cassette load system with an intuitive LCD touch screen. Several asor friendry casbette four pedal and a remote control are available as optional features. The NeXtra™ is to be used exclusively with specific FMS tube sets.
    Ask a Question
    K Number
    K024185
    Device Name
    BIODHOC
    Manufacturer
    FUTURE MEDICAL SYSTEMS, SA
    Date Cleared
    2004-01-15

    (392 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTURE MEDICAL SYSTEMS, SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BIODHOC is an implant used for rotator cuff repair in shoulder surgery.
    Device Description
    The BIODHOC is an implant used for rotator cuff repair in shoulder surgery. The BIODHOC is made of poly DL- lactic acid (PLLA) a bio absorbable polymer.
    Ask a Question

    Page 1 of 1