BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MedCAD AccuShape Titanium Patient-Specific Cranial Implant

    K Number: K220357 · Decision Aug 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    9
    Review Days
    199

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    Basic Information

    Device Name
    MedCAD AccuShape Titanium Patient-Specific Cranial Implant
    K Number
    K220357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medcad
    Date Received
    February 8, 2022
    Decision Date
    August 26, 2022
    Product Code
    GXN
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXN Plate, Cranioplasty, Preformed, Non-Alterable

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    Other Clearances by Medcad

    K Number Device Name
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    K223421 MedCAD AccuPlan Orthopedics System
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