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

    MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE

    K Number: K915139 · Decision Feb 5, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    55
    Applicant Total
    15
    Review Days
    84

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    Basic Information

    Device Name
    MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE
    K Number
    K915139
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Micro Surgical Instruments Corp.
    Date Received
    November 13, 1991
    Decision Date
    February 5, 1992
    Product Code
    HSZ
    Advisory Committee
    General, Plastic Surgery
    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
    HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

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