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MEDINAUT Plus Kyphoplasty System is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

The MEDINAUT Plus Kyphoplasty System is designed to reduce compression fracture and create a void in cancellous bone in the spine. By creating a space in the operating point, the major benefits of MEDINAUT Plus Kyphoplasty System are the reduction in pain and the increase of patient s functional abilities, which allow for the patient's return to the previous level of activity. The MEDINAUT Plus Kyphoplasty System consists of the Balloon Expander, Balloon Catheter, Cement Dispenser System, Cement Mixer System and Syringe. The Balloon Catheter consists of an inner-outer tube, Y-port and an inflatable balloon located at the distal tip. The radiopaque markers located at the distal and proximal end allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Expander consists of a gauge, housing, a half nut, a plunger, a piston, a hose, a luer connector and a 3 way valve. The Balloon Expander is used for inflating the balloon by rotating the plunger clockwise. The lock mechanism maintains pressure. The Cement Dispenser System consists of Cannula, Needle (3 types: Bevel, Diamond, Trocar), Spacer, Biopsy, Biopsy Cap. Cement Filler, Cement Pusher and Cement Side Filler. The Cement Mixer System consists of Cement Mixer, Tube, Cap, Funnel and Pusher. The user can mix cement inside the cylinder by moving the mixer up and down repeatedly and apply the cement into a patient by rotating the pusher handle. The Syringe is an optional device. If there is air found in the Catheter Balloon before surgery, the user can remove the air with this syringe. All the components including Balloon Expander, Balloon Catheter, Cement Dispenser System. Cement Mixer System and Syringe are supplied sterile and are disposable.

For administration of anesthetic agents into the epidural space to provide epidural or caudal anesthesia.

EPINAUT Spring Guide Epidural Catheter is constructed of a stainless steel continuous spring. EPINUAT Spring Guide Epidural Catheter offers two types of catheter. The catheter types, L330 & L600 have an uncoated distal tip which is flexible, smooth and rounded with coils slightly spread for maximum flexibility and lateral distribution of injectant. The other catheter types, C310 & C600 have a distal end which is entirely coated by tube for maximum smoothness. There are 16 models in EPINAUT: L33011320, L33013820, L33011315, L33013815, L60011320, L60013820, L60011315, L60013815, C31011320, C31013820, C31011315, C31013815, C60011320, C60013820, C60011315 and C60013815. Each model is characterized by different length of catheter, length and outer diameter of wire, inner diameter of adapter, length and diameter of introducer needle and needle cap. EPINUAT Spring Guided Epidural Catheter have enhanced tensile/ break strength and restrict longitudinal catheter stretch, while the spring coils make the catheter resistant to kinking and collapsing. Wire is also provided with the device which consists of a stainless steel and a molded plastic hub. The introducer needle is inserted into the epidural space through the sacral hiatus under intermittent fluoroscopy. After appropriate determination of the epidurogram and target area, the catheter with the wire in it is advanced through the introducer needle to the concerned area as determined by MRI or symptomatology. When the catheter is approached to target site, the wire is removed from the catheter and then the medication can be injected by attaching the adapter to a syringe.

The MEDINAUT Kyphoplasty System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, radius, and calcaneus. This includes percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

The MEDINAUT Kyphoplasty System is designed to reduce compression fracture and create a void in cancellous bone in the spine, tibia, radius, and calcaneus. Bone cement insertion using cement dispensing plunger is applied for spinal use only. The MEDINAUT Kyphoplasty System consists of the MEDINAUT-X (Inflatable Bone Expander System) and MEDINAUT-I (Cement Dispenser System). The MEDINAUT-X is comprised of a Balloon Catheter and a Bone Expander Syringe. The Balloon Catheter's main components are the shaft, Y-hub and the inflatable balloon located at the distal tip. The inflatable balloon is covered with a maximum 0.03g of silicone fluid to enhance lubricity when the balloon catheter is inserted in the cannula. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Catheter and Bone Expander Syringe are supplied sterile and are disposable. The MEDINAUT-I is a cement dispenser system consisting of a Needle Pipe, Needle Pin, Wire Pin, Cannula, Expander, Spacer, Cannula Expander, Cement Pusher, Cement Filler, and Guide Wire. They are supplied sterile and are disposable.

The SPINUAT-P is indicated for ablation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

The SPINAUT-P is a minimally invasive RF electrode device offered in 496mm length for percutaneous disc decompression surgery using radiofrequency energy and designed for use with radiofrequency generators in RF procedure. SPINAUT-P is intended to be placed into the epidural space or posterolateral / posterocentral area in the disc to remove, ablate or coagulate disc material in the area. The electrode consists of two stainless steel shafts with straight electrode configuration design. The shaft is housed in a coating composed of Polyamide. The device is single-use gamma radiation sterilized and is compatible with most standard electrosurgical generators that provide a cable with two pin outlet (2-pin, 22mm) with 1kVp maximum electrical capacity.

When used with a fiberoptic endoscope, SPINAUT-V can be used for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications. The SPINAUT-S is intended to be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease. SPINAUT-I is intended for the percutaneous introduction and placement of a video guided catheter and/or an endoscope.

SPINAUT-V consists of a flexible catheter, steering handle and associated ports for access to the lumen. The catheter has built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. The design allows the use of a flexible fiber optic endoscope for visual examination of the area and surrounding tissues at the distal end of the catheter. This visual examination then allows the physician to diagnose the potential causes of neural distress and pain. SPINAUT-V is a sterile, single use device. When placing SPINAUT-V into the patient, SPINAUT-I can be used instead of SPINUT-V as an introducer device. SPINAUT-S is a surgically invasive flexible fiberoptic system that can be used either with a video guided catheter (SPINAUT-V or other video guided catheters with proper catheter size) or with an introducer device such as SPINAUT-I. The SPINIUT-S is a reusable device that is supplied non-sterile with instructions for cleaning, sterilization and re-use. The SPINAUT-S can be used with the light source and camera system. SPINAUT-I is intended to be used to prepare or preserve a path for a video guided catheter or an endoscope. It is supplied sterile and for single use.

SPINAUT-E is used for delivery of drugs that have been indicated for the epidural space. SPINAUT-I is intended for the percutaneous introduction and placement of an epidural catheter.

SPINAUT-E consists of a flexible catheter, steering handle and a port for access to the lumen. The catheter has built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. The port facilitates the connection of syringes to deliver therapeutic agents by physicians as appropriate to their diagnosis. It is supplied sterile and it is for single use. There are 9 models in SPINAUT-E: E1000, E2000, E1100, E2100, E3100, S1000, S2000, and S3000. The catheter tip of the model E1000, and E3000 can be bent 50° to the left or to the right (the user can rotate the tip to adjust the direction), but the tip of the model E1100, E2100, and E 3100 can be bent either direction up to 100°. The S1000, S2000, and S3000 have an extra infusion port for drug so that the other main port can be used for other devices. Each model is characterized by the additional port, the lever, and the dimensions. The SPINAUT-I is intended to be used to prepare or preserve a path for an epidural catheter. When placing SPINAUT-E into the patient, SPINAUT-I can be used as a replacement of the SPINUT-E Catheter Introducer Set. It is supplied sterile and it is for single use. There are 3 models in SPINAUT-I: ID1000, ID2000, and ID3000 and each model is characterized by the length.

The MEDINAUT Kyphoplasty System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

The MEDINAUT Kyphoplasty System is designed to reduce spinal compression fracture and restore sagittal alignment. By creating a space in the vertebral body it facilitate the insertion of bone cement through the use of the cement dispensing plunger. The benefits of MEDINAUT Kyphoplasty System are the reduction in back pain and increase of patient's functional abilities, allowing a return to the previous level of activity. It consists of Balloon Catheter, Bone Expander Syringe, Needle Pipe, Needle Pin, Wire Pin (Troca Type, Round Type), Cannula, Expander, Spacer, Cement Pusher, Cement Filler, and Guide Wire. It is supplied sterile and for single disposable use. The MEDINAUT Kyphoplasty System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The system is substantially equivalent in design, function and intended use to the predicate devices.