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

    RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS

    K Number: K880074 · Decision Mar 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    74

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    Basic Information

    Device Name
    RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS
    K Number
    K880074
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Romano Surgical Instrumentation, Inc.
    Date Received
    January 11, 1988
    Decision Date
    March 25, 1988
    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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    Other Clearances by Romano Surgical Instrumentation, Inc.

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    K885229 MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS