Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K133082
    Device Name
    OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
    Manufacturer
    OSTEOSYMBIONICS, LLC
    Date Cleared
    2014-05-20

    (232 days)

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

    OSTEOSYMBIONICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OsteoSymbionics Patient-Specific Cranial Implants are designed individually for each patient to correct cranial defects.
    Device Description
    The OsteoSymbionics Patient Specific Cranial Implants are individually sized and shaped implantable prosthetic cranioplasty plates intended to fill cranial defects in a specific patient. The implants are composed of polymethyl methacrylate and are fabricated using the patient's CT imaging data. The devices are provided sterile and are attached to the native bone with commercially available cranioplasty fasteners.
    Ask a Question
    K Number
    K121102
    Device Name
    OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
    Manufacturer
    OSTEOSYMBIONICS, LLC
    Date Cleared
    2012-08-08

    (119 days)

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

    OSTEOSYMBIONICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OsteoSymbionics PK Shield (PEEK Patient Specific Cranial Implant) is designed individually for each patient to correct defects in cranial bone.
    Device Description
    OsteoSymbionics Patient-Specific Cranial Implant (PEEK), manufactured by OsteoSymbionics, LLC, is a prosthetic cranioplasty implant. Each implant is sized and shaped from one or more pieces to fit the specific patient's cranial skeleton. The devices are manufactured from PEEK and provided non-sterile for sterilization prior to implantation. Implantable prosthetic cranioplasty implants are intended to fill a specific patient's defect, so each device is manufactured one at a time to custom-order based upon the patient's CT scan. The device can be crafted to include perfusion holes (2mm in diameter, spaced 10mm apart) upon surgeon preference (on order sheet). The implants are attached to the native bone with commercially available cranioplasty fasteners.
    Ask a Question
    K Number
    K111069
    Device Name
    OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT
    Manufacturer
    OSTEOSYMBIONICS, LLC
    Date Cleared
    2011-09-22

    (157 days)

    Product Code
    MNF
    Regulation Number
    878.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOSYMBIONICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OsteoSymbionics ST Temporalis Implant is indicated to correct temporal hollowing in patients who have had surgery involving the pterional / lateral approach to the cranium, including pterional / lateral craniotomy or decompressive craniectomy. The OsteoSymbionics ST Temporalis Implant augments the space normally occupied by the temporalis muscle. The implant is used for the reconstruction of temporal contour deformities; the reconstruction of temporal defects, and / or the augmentation / reconstruction of the space normally occupied by the temporalis muscle / temporal area (s).
    Device Description
    The OsteoSymbionics Temporal Implants are pre-formed implantable prosthetic implants intended to fill soft-tissue defects in a patient's cranial/craniofacial temporal region. The implants are composed of longterm implantable-grade solid silicone elastomer. The implants are available in left and right, and come in two different sizes, small and medium. The devices are provided sterile, and are attached to native tissue with commercially available suture materials.
    Ask a Question
    K Number
    K072601
    Device Name
    OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
    Manufacturer
    OSTEOSYMBIONICS, LLC
    Date Cleared
    2007-12-10

    (87 days)

    Product Code
    GXP, GXN
    Regulation Number
    882.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOSYMBIONICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OsteoSymbionics Patient Specific Cranial Implants are designed individually for each patient to correct defects in craniofacial bone.
    Device Description
    The OsteoSymbionics Patient Specific Cranial Implants are individually sized and shaped implantable prosthetic cranioplasty plates intended to fill defects in a specific patient's cranial/craniofacial skeleton. The implants are composed of polymethyl methacrylate and are fabricated using the patient's CT imaging data. The devices are provided non-sterile for sterilization prior to implantation and are attached to the native bone with commercially available cranioplasty fasteners.
    Ask a Question

    Page 1 of 1