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

    ZIMMER VACUUM MIXING SYSTEM

    K Number: K861086 · Decision Apr 14, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    12
    Applicant Total
    376
    Review Days
    24

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    Basic Information

    Device Name
    ZIMMER VACUUM MIXING SYSTEM
    K Number
    K861086
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4210
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Zimmer, Inc.
    Date Received
    March 21, 1986
    Decision Date
    April 14, 1986
    Product Code
    JDZ
    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
    JDZ Mixer, Cement, For Clinical Use

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