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

    ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)

    K Number: K902168 · Decision Jun 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    40
    Review Days
    36

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    Basic Information

    Device Name
    ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)
    K Number
    K902168
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Micro-Aire Surgical Instruments, Inc.
    Date Received
    May 15, 1990
    Decision Date
    June 20, 1990
    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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    K900033 MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS
    K900210 BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500
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