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510(k) Data Aggregation

    K Number
    K240567
    Device Name
    CustomizedBone Service
    Manufacturer
    Fin-ceramica faenza s.p.a.
    Date Cleared
    2024-03-28

    (28 days)

    Product Code
    GXN, PJN
    Regulation Number
    882.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fin-ceramica faenza s.p.a.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and/or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of age and above). CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from: - trauma and vascular pathologies, either associated or non-associated to cranial decompression; - removal of tumours; - reabsorption of autologous bone; - rejection of other prosthetic materials; - congenital malformations.
    Device Description
    CustomizedBone Service patient specific implants for the reconstruction of cranial/craniofacial defects are made of porous biomimetic hydroxyapatite with a chemical composition and structure that resembles the mineral component of human bones. This biomaterial is highly porous with trabecular structure and is composed of pores with the following characteristics: - macro-pores, - interconnecting pores, - micro-pores. This material is biocompatible. The implants are designed and produced by Fin-Ceramica Faenza according to the surgeon's specifications and based on the patient's CT scan data, obtained through a standardized protocol. During the pre-operative planning phase, the final implant design. All the implants are accompanied by the patient's identification code.
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