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

    MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER

    K Number: K821695 · Decision Jul 20, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    93
    Registration Numbers
    93
    Same Product Code
    3
    Applicant Total
    40
    Review Days
    42

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    Basic Information

    Device Name
    MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER
    K Number
    K821695
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Micro-Aire Surgical Instruments, Inc.
    Date Received
    June 8, 1982
    Decision Date
    July 20, 1982
    Product Code
    HTT
    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
    HTT Burr, Orthopedic

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    Other Clearances by Micro-Aire Surgical Instruments, Inc.

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    K901967 DENDIA WERK BURS AND CUTTING DISCS
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    K902168 ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)
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