LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K193547
    Device Name
    CustomizedBone Service
    Manufacturer
    Fin-Ceramica Faenza Spa
    Date Cleared
    2020-01-17

    (28 days)

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

    Fin-Ceramica Faenza Spa

    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
    Not Found
    Ask a Question
    K Number
    K171507
    Device Name
    CustomizedBone Service
    Manufacturer
    Fin-ceramica faenza spa
    Date Cleared
    2017-09-01

    (101 days)

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

    Fin-ceramica faenza spa

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children above 13 years of age). 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
    Not Found
    Ask a Question
    K Number
    K160707
    Device Name
    CustomizedBone Service
    Manufacturer
    FIN-CERAMICA FAENZA SPA
    Date Cleared
    2016-12-17

    (278 days)

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

    FIN-CERAMICA FAENZA SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children above 13 years of age). CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from: - · trauma and vascular pathologies, either associated or non-associated to cranial decompression; - · removal of tumors; - · reabsorption of autologous bone; - · rejection of other prosthetic materials; - · congenital malformations.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1