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

    MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS

    K Number: K885229 · Decision Sep 29, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    294

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS
    K Number
    K885229
    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
    December 9, 1988
    Decision Date
    September 29, 1989
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HSZ), ordered by most recent decision date.

    EMS SWISS ORTHOCLAST

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CURVTEK TSR SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ALIGNMENT INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ASPACH 65,000 (MODIFICATION)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SODEM HIGH SPEED SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ETHICON DRILL BIT AND DRILL GUIDE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Romano Surgical Instrumentation, Inc.

    K Number Device Name
    K880074 RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS