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Aesthetic Body Contouring

The Vitruvian Liposaber™ consists of a control unit with an interconnecting cable to power and control a handpiece. The handpiece employs a motor intended to imitate the surgeons repetitive back and forth motions used during the liposuction procedure. The handpiece holds the cannula and the vacuum tubing. The handpiece is controlled by the user through the interaction with the control unit. The control unit controls the speed of the motor in the handpiece which provides the reciprocating motion of the cannula. The speed of the motor is variable between 3000 and 5000 RPM. The nominal speed is 4000 which can be adjusted using the controls on the handpiece between 3000 and 4000 RPM. Adjustments higher than 4000 must be performed through the user interface on the control unit.

The Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

The Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136.

The FUSE Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

The FUSE Pedicle Screw System consists of longitudinal rods and polyaxial screws. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136.

The Stowe Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

The STOWE Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136.

Aesthetic body contouring

The B89055 Vitruvian Infiltration Pump is intended to be used for aesthetic body contouring. Normal use includes general tumescent infiltration. It has a self-adjusting power converter which works with either 100V or 240V currents, and includes a pneumatic foot-switch and selfadjusting tubing guide to prevent tubing slippage during operation. It has a fully adjustable flow rate between 0 mL/min and 475 mL/min. The Vitruvian Infiltration Pump is a pre-assembled device consisting of: - Housing: ABS Plastic - Power Operation: 100-240VAC, 50-60Hz, 1.8-1.0A - Head: 3 roller peristaltic action - Control: Knob used to set mL/min - Display: LED - Foot Switch: Air Powered ON/OFF - Power Cord: Yes The infiltration pump does not contact the patient.

The IDSS-ForceTriad Control Module is designed for integration in the IDSS(Integrated Digital Surgical Suite) and enables the Covidien ForceTriad Energy Platform to be controlled remotely.

The IDSS ForceTriad Control Module is an additional function to the IDSS, which is an integrated operating room system controlling video displays, observation cameras, audio video equipment, teleconferencing and the routing of video and images from multiple sources to multiple destinations via a touch screen interface. With the IDSS ForceTriad Control Module, operation room staff is able to control the ForceTriad setup from the touch panel location rather than using the ForceTriad unit itself.

Aesthetic body contouring.

The Vitruvian Aspirator is a pre-assembled device consisting of: - . Housing: Powder Coated Steel - . Vacuum Pump: Dual ½ hp dual voltage rocking piston motor with Maximum Suction flow rate of 125PSI, 6.4 cfm, 27.5in HG(711 mm of Hg) - . Vacuum Meter Display: The device displays the vacuum levels digitally. The software does not control the unit in any way and does not accept any input. - . Power Operations: 120/230 volt 50/60hz - . Control: Pressure control valve located on the face of the device with rotary control knob with both LED numerical and Color Graphic LED display - . Footswitch: Dual activated air powered - IV Pole . - . Filter: Bacterial filter having a pore size of 0.3 microns or less.

IDSS SLC allows the control of surgical lighting during a surgical procedure from the IDSS, which is a centralized interface for voice, video, audio, observational camera and teleconferencing for the operating room.

IDSS SLC is an additional function of the IDSS, which is an integrated operating room system that controls video displays, observation cameras, audio video equipment, teleconferencing and the routing of videos and images from multiple sources to multiple destination via touch screen interface.

The aspiration and infusion cannulae and needles are indicated for aesthetic body contouring and general tissue aspiration.

Black and Black Surgical Cannulae and Needles are used to remove fluid, soft tissue, and exudates and infusion, utilizing a hollow stainless steel tube and multiple tips, handle and attachment connectors that are in reusable and disposable configuration. They are used during general, plastic, and reconstructive procedures.

The Black and Black Surgical monopolar electrodes and forceps are reusable devices intended for use in surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic, arthroscopic) where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate soft tissue.

The Black and Black monopolar forceps and electrodes are handheld, reusable devices designed to deliver monopolar RF electrosurgical energy to a surgical site to cut and/or coagulate tissue. The surgeon activates the desired electrosurgical mode from the sterile field by using buttons on the device. Three electrosurgical modes are available: Cut: cuts tissue with minimal coagulation / hemostasis; Hemostasis with Division: divides tissue with controlled hemostasis; Coag: coagulates bleeding vessels to promote hemostasis.