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

    SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY

    K Number: K893136 · Decision Dec 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    19
    Review Days
    233

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    Basic Information

    Device Name
    SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY
    K Number
    K893136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Dyonics, Inc.
    Date Received
    April 25, 1989
    Decision Date
    December 14, 1989
    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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    Other Clearances by Dyonics, Inc.

    K Number Device Name
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    K894728 DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE
    K892062 PS3500 ARTHROSCOPIC SURGICAL SYSTEM
    K884839 MODIFIED SAW BLADES TO THE SAGITAL SAW
    K881876 DYNAMIC CRUCIATE TESTER
    K880739 DYONICS DRILL GUIDE/ISOMETER SYSTEM
    K880150 PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM
    K870212 ARTHROSCOPIC SHOULDER HOLDER
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