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

    ECTRA II LIGAMENT RELEASE SYSTEM

    K Number: K954627 · Decision Dec 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    22
    Review Days
    73

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    Basic Information

    Device Name
    ECTRA II LIGAMENT RELEASE SYSTEM
    K Number
    K954627
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Smith & Nephew Dyonics, Inc.
    Date Received
    October 6, 1995
    Decision Date
    December 18, 1995
    Product Code
    HRX
    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
    HRX Arthroscope

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