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

    OSTEOSYMBIONICS PEEK CRANIAL IMPLANT

    K Number: K121102 · Decision Aug 8, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    4
    Review Days
    119

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    Basic Information

    Device Name
    OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
    K Number
    K121102
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteosymbionics, LLC
    Date Received
    April 11, 2012
    Decision Date
    August 8, 2012
    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 Osteosymbionics, LLC

    K Number Device Name
    K133082 OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
    K111069 OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT
    K072601 OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT