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The Osteo-site® Vertebral Balloon is intended to be used for the reduction and fixation of a void in cancellous bone in the spine for Kyphoplasty. The Osteo-site® Vertebral Balloon is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for Kyphoplasty.

The Osteo-site® Vertebral Balloon consists of a Y-connector with luer fitting, catheter with mandrel, and a balloon with radiopaque markers. The Y-connector is adhered to a strain relief fitting which is then adhered to the proximal end of the outer shaft. The mandrel ball is placed in a socket at the proximal end of the Y-connector that is coaxial to the catheter. The distal end of the catheter is welded to the proximal end of the balloon and the distal end of the mandrel is screwed into the distal end of the balloon. This construction allows for fluid to fill from the angled section of the Y-connector, around the mandrel, and into the balloon without obstruction. The mandrel can move freely longitudinally until the ball end meets the limits of the socket at the proximal end of the Y-connector. This controls the balloon expansion longitudinally. The radiopaque markers at the distal end of the mandrel are an imaging reference of balloon placement for the user. The proximal markers are visual indication of the balloon's placement. The exterior surface of the balloon is covered by a lubricant which eases access through the introducer cannula.

The Navigated Pedicle Access Kit is intended to be used in image guided surgery with the 7D Surgical System. The Navigated Pedicle Access Kit is intended for use in posterior spinal surgery to assist in the acurate placement of pedicle screws. The device is sterile and designed for single use.

The IZI Pedicle Access Kit consists of one pedicle access needle with cannula. The handle contains 4 retro-reflective Navigation Markers (Spherz K022074). The device is sterile and designed for single use. The patient-contacting components are the stainless-steel cannulas and needle. The product is used to gain access to the pedicle in image guided surgeries using the 7D Surgical System. The retro-reflective Navigation Markers (Spherz) that are attached to the handle allows the camera system of 7D Surgical System (K180352) to accurately locate where the tip of the needle is in space.

The CushionCast™ Moldable Cushion is to be used by trained medical professionals for stable support and positioning of patients undergoing radiation therapy or other treatment in a clinic or hospital setting.

The CushionCast™ is moldable stabilization cushions for radiation therapy patients. This product targets customers who require stabilization cushions for patients who are undergoing radiation therapy. The CushionCast™ is needed in order to mold to the shape of the patient's head to immobilize any movement during radiation therapy. The cushion is constructed with a biocompatible and water resistant fabric and internal components, which include low viscosity casting resins that are sealed in pouches and polystyrene beads as filler material. To activate the cushion, the pouches are popped, and the internal components are mixed for 2 minutes. The plug inserted in the vent tube is removed prior to the molding process. The vent tube serves to expel excess air to allow for an accurate mold. The mixture of the Part A and Part B liquid plastics should yield a hardened mold. The fully cured mold provides a dimensionally stable cushion required by radiotherapy systems.

The MDT Navigable Brain Biopsy Cannula is for use in stereotaxic biopsy of cranial tissue. The MDT Navigable Brain Biopsy Cannula is a pre-sterilized, single-use, sidecutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula. The device is compatible with Medtronic's StealthStation® Image Guided Surgery System.

The MDT Navigable Brain Biopsy Cannula contains a calibrated biopsy cannula that is used with a compatible image guided surgery navigation system in stereotaxic biopsy of cranial tissue. The device is compatible with Medtronic's StealthStation® Image Guided Surgery System. Like the predicate devices, both devices are pre-sterilized, single-use, stainless steel devices and use a side-cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula. The MDT Navigable Brain Biopsy Cannula components include a navigable biopsy cannula, a biopsy cannula stop with screw, a stop adjustment tool and an aspiration tube.

The Disposable Passive Accessory is intended to be used for anatomy palpation in image guided surgeries with Medtronic StealthStation® System. The device is sterile and designed for single use.

The IZI Disposable Passive Accessory contains one disposable point probe mounted with five passive reflective sphere markers, as well as ten additional passive reflective sphere markers. The Disposable Passive Accessory is intended to be used for anatomy palpation and registration in image guided surgeries with the Medtronic StealthStation® system. The device is sterile and designed for single use. The Disposable Passive Accessory provides a single-use alternative to Medtronic reusable parts. The Disposable Passive Accessory is constructed by a dimension stable thermoplastic handle where five passive reflective sphere markers are mounted on, with a stainless steel tip that is used to register and locate patient anatomical structure in an image guided surgery using the Medtronic StealthStation® System. The permanently mounted passive reflective spheres are at the same three dimensional locations as the Medtronic predicate product. In an IGS procedure, the two cameras of the StealthStation® captures the reflective light from the five sphere markers for the System to calculate and determine the location of the stainless tip and the position of the probe.

The BL Navigated Biopsy Needle is indicated for stereotactic biopsy of cranial tissue using BrainLab AG's VectorVision navigation system. The Navigated Biopsy Needle is a pre-sterilized, single-use, side-cutting needle where the cutting action is achieved by rotation of an inner cannula within an outer cannula.

BL Navigated Biopsy Needle contains a calibrated biopsy cannula that is used with a compatible image guided surgery navigation system in stereotactic biopsy of cranial tissue. The device is compatible with specified BrainLab navigation systems (see intended use section below). Like the predicate device, the BL Navigated Biopsy Needle is a pre-sterilized, single-use, stainless steel device and uses a side-cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula. BL Navigated Biopsy Needle's components include a navigable biopsy cannula, a biopsy cannula stop with screw, a stop adjustment tool and an aspiration tube.

emBRACE is intended to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray technology.

emBRACE is a radiolucent foam cushion used during radiologic visualization of the breast. emBRACE is non-sterile and is a single use device. emBRACE will be offered in the following configurations for ease of use dependent o the radiological system used: - Product Number 00283-001 for use on an 18x24cm bucky. . - Product Number 00283-100 for use on a 25x29cm bucky. . - Product Number 00283-200 for use on a 29x30cm bucky. .