BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PNEUMATIC WIRE TENSIONER

    K Number: K942760 · Decision Sep 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    55
    Applicant Total
    87
    Review Days
    85

    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
    PNEUMATIC WIRE TENSIONER
    K Number
    K942760
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Richards, Inc.
    Date Received
    June 13, 1994
    Decision Date
    September 6, 1994
    Product Code
    HSZ
    Advisory Committee
    General, Plastic Surgery
    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
    HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

    Similar 510(k) Clearances

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

    EMS SWISS ORTHOCLAST

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CURVTEK TSR SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ALIGNMENT INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ASPACH 65,000 (MODIFICATION)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SODEM HIGH SPEED SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ETHICON DRILL BIT AND DRILL GUIDE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Smith & Nephew Richards, Inc.

    K Number Device Name
    K965224 EMPOWER ANTERIOR DIRECT SCREWS
    K963509 GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON
    K960444 FINN ROD TO ROD CONNECTOR
    K964163 TRIMAX NAIL SYSTEM
    K962557 GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
    K963486 REVISION HIP SYSTEM
    K962541 REFLECTION ACETABULAR REINFORCEMENT RINGS
    K962808 ILIZAROV EXTERNAL FIXATION SYSTEM
    K962137 GENESIS II CONSTRAINED SYSTEM
    K955767 COFIED MODULAR SHOULDER SYSTEM
    Search all 87 clearances from Smith & Nephew Richards, Inc. →