BEUDAMED
    Product Code: GXM FDA class 1 21 CFR 882.4030

    Anvil, Skull Plate

    Neurology

    The Skull Plate Anvil is a manual neurosurgical instrument used to shape or support skull plates during cranioplasty procedures, providing a solid backing surface when forming or fitting cranial fixation hardware. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is GXM under regulation 21 CFR 882.4030 in the Neurology medical specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.

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    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    GXM
    Device Class
    FDA class 1
    Regulation Number
    882.4030
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.