BEUDAMED
    Product Code: HBX FDA class 1 21 CFR 882.4500

    Instrument, Cranioplasty Material Forming

    Neurology

    The Cranioplasty Material Forming Instrument is a surgical tool used to shape malleable cranioplasty materials, such as methyl methacrylate, into the correct form to fill and cover cranial defects before the material sets or is implanted. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HBX under regulation 21 CFR 882.4500 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.

    View on FDA
    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HBX
    Device Class
    FDA class 1
    Regulation Number
    882.4500
    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 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.