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    K Number
    K150455
    Device Name
    RT2 Trabeculite Titanium Cervical Cage System
    Manufacturer
    RHAUSLER, INC.
    Date Cleared
    2015-11-19

    (272 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    RHAUSLER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rhausler RT2 Trabeculite Titanium Cervical Cage System is intended for spinal fusion procedures at one level (C3-T1) in skeletally mature patients with cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have at least 6 weeks of nonoperative treatment. This device is intended to be used with supplemental spinal fixation systems.
    Device Description
    The Rhausler RT2 Trabeculite Titanium Cervical Cage System is a cervical intervertebral body fusion device. The system is comprised of implants and instruments. The instruments are utilized for the implantation procedure. All implants are manufactured from medical grade Titanium alloy (Ti6 Al 4V). The implant is rectangular in shape with lordotic configuration, i.e., with 4 degree profiles. It is offered in two cross sectional sizes and is available in various height options to accommodate variations in patient anatomy. The center of the implant has a hollow cylindrical shape fenestration for placement of autogenous bone. Trabeculite Titanium Cervical Cage implant is provided sterile.
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    K Number
    K111272
    Device Name
    RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
    Manufacturer
    RHAUSLER, INC.
    Date Cleared
    2011-11-29

    (209 days)

    Product Code
    OVE
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    RHAUSLER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have had at least 6 weeks of nonoperative treatment.
    Device Description
    The Rhausler Plage Anterior Cervical Fusion System consists of titanium plage (one piece cervical plate and cage) implants, titanium locking bone screw implants, and instruments. Implants are provided in a variety of dimensions. The Plage is designed with slots for bone screw placement. The Plage center lower cage portion is open to allow the opening to be filled with autogenous bone. The Plage System is provided nonsterile.
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