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510(k) Data Aggregation

    K Number
    K133285
    Device Name
    STRYKER TEMPORARY CONDYLAR PROSTHESIS
    Manufacturer
    Stryker
    Date Cleared
    2014-04-09

    (166 days)

    Product Code
    NEI
    Regulation Number
    872.4770
    Why did this record match?
    Product Code :

    NEI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stryker Temporary Condylar Prostheses are intended for temporary (not exceeding 24 months) reconstruction in patients undergoing ablative tumor surgery requiring removal of the mandibular condyle.
    Device Description
    The Stryker Temporary Condylar Prosthesis is an independent solid condylar head which is rigidly connected to a standard or locking Stryker Reconstruction plate via fastening screws. The Temporary Condylar Prosthesis is provided in a left and right configuration and is intended for temporary use only (not exceeding 24 months). The Condylar Prosthesis is made of commercially pure titanium and the head of the condyles is PVD (Physical Vapor Deposition) coated which differentiates it from the rest of the condyles giving it golden color. The Temporary Condylar Prosthesis is accompanied by connecting screws which are made of commercially pure titanium alloy and are specifically designed to fixate the Prosthesis with a Stryker plate.
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    K Number
    K081747
    Device Name
    MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2008-09-05

    (78 days)

    Product Code
    NEI
    Regulation Number
    872.4770
    Why did this record match?
    Product Code :

    NEI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
    Device Description
    The Synthes Condylar Head Add-on System is an adjustable height add-on system for use with the 2.4 mm Locking Reconstruction Plate System and MatrixMANDIBLE Plate System. It consists of a condylar head, 2 screws, and one of four (4) fixation plates, each with a different screw hole spacing that determines the height of the condylar head.
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    K Number
    K063181
    Device Name
    SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2007-01-05

    (78 days)

    Product Code
    NEI
    Regulation Number
    872.4770
    Why did this record match?
    Product Code :

    NEI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
    Device Description
    The Synthes (USA) Condylar Head Add-on System is an adjustable height system intended for use with Synthes' 2.4 mm Locking Reconstruction Plate (LRP) System. The system consists of an elliptical shaped condylar head, four different fixation plates which allow the surgeon to adjust the height of the condylar head, and two fixation screws for mounting the condylar head and fixation plate onto a 2.4 mm locking reconstruction plate.
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    K Number
    K031701
    Device Name
    OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM
    Manufacturer
    OSTEOMED L.P.
    Date Cleared
    2004-07-08

    (402 days)

    Product Code
    NEI
    Regulation Number
    872.4770
    Why did this record match?
    Product Code :

    NEI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is not intended for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). Implants are intended for single patient use.
    Device Description
    The OsteoMed Temporary Condylar Attachment system is a solid condylar head which attaches with fastening screws to an OsteoMed Fracture Reconstruction Plate. The OsteoMed Temporary Condylar Attachment is available for right and left placement. System instruments include drivers.
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    K Number
    K002790
    Device Name
    ADD-ON CONDYLE
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Date Cleared
    2001-08-06

    (333 days)

    Product Code
    NEI
    Regulation Number
    872.4770
    Why did this record match?
    Product Code :

    NEI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990667
    Device Name
    KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
    Manufacturer
    KLS-MARTIN L.P.
    Date Cleared
    2001-07-27

    (878 days)

    Product Code
    NEI
    Regulation Number
    872.4770
    Why did this record match?
    Product Code :

    NEI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KLS-Martin Temporary Condylar Implant is only intended for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
    Device Description
    The KLS-Martin Temporary Condylar Implant is a solid condylar head which attaches with fastening screws to a KLS-Martin Fracture/Reconstruction Plate. The KLS-Martin Temporary Condylar Implant is available for left and right placement.
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    K Number
    K990637
    Device Name
    SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    1999-10-22

    (238 days)

    Product Code
    NEI
    Regulation Number
    872.4770
    Why did this record match?
    Product Code :

    NEI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synthes (USA) Locking Reconstruction Plate with Condylar Head is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
    Device Description
    The Locking Reconstruction Plate with Condylar Head is a one piece reconstruction plate with a solid condylar head. The plate features compression screw holes that are internally threaded to accept the 2.4 - 3.0 mm locking screws or standard 2.4 mm self-tapping cortex screws and has notched sides and undersides to facilitate contouring. The plates are available in three sizes for right and left placement.
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