BEUDAMED
    Product Code: GZQ FDA class 2 21 CFR 882.4275

    Instrument, Dowel Cutting

    Neurology

    The Dowel Cutting Instrument is a neurosurgical device used to cut bone dowels or plugs, typically for use in spinal fusion procedures where bone graft material is shaped and inserted between vertebrae to promote fusion. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GZQ under regulation 21 CFR 882.4275 in the Neurology specialty. It is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    GZQ
    Device Class
    FDA class 2
    Regulation Number
    882.4275
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K893874 FUJITENS III

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.