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

    DRIVERS

    K Number: K781450 · Decision Sep 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    1
    Applicant Total
    45
    Review Days
    35

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    Basic Information

    Device Name
    DRIVERS
    K Number
    K781450
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Orthopedic Equipment Co., Inc.
    Date Received
    August 23, 1978
    Decision Date
    September 27, 1978
    Product Code
    GFC
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GFC Driver, Surgical, Pin

    Similar 510(k) Clearances

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

    NEEDLE DRIVER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
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    Other Clearances by Orthopedic Equipment Co., Inc.

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    K781445 SPREADER
    K790247 TOURNIQUET TEST GAGE
    K790209 FILTER SYSTEM, ALTNER DISPOSABLE
    K781444 OUTRIGGER DISTRACTION UNIT
    K781451 FLAT WRENCH
    K781447 THREADED ROD CLAMP
    K781449 HARRINGTON SPINAL ELEVATOR
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