VIVALNK, INC. A13 Hydrogel Adhesive

Precision Thin Offset (10.0 x 0.38 x 43.0mm)

Set Includes the following: 242-100-008 : 2.5 mm Grasper 242-100-004 : 2.1 mm Left Blunt Nose Grasper 242-100-005 : 2.1 mm Down Blunt Nose Grasper 242-100-006 : 2.1 mm Up Blunt Nose Grasper 242-100-002 :2.1 mm Straight Blunt Nose Grasper 242-100-012 : 2.7 mm Straight Blunt Nose 242-100-007 : 2.5 mm Championª Scissors 242-100-013 : 2.7 mm Up Blunt Nose

The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN steerable needle to fill the previously created void(s). An access channel is required for the Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device.If the balloon has an Articulating Stylet inserted it enables the steerable feature of the balloon. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existing channel. The Osseoflex® SB actuation knob can be turned clockwise to aid in directing the distal portion of the device. Turning the actuation knob counter-clockwise will relax the device and allow the device to be returned to it's start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

Zip 4 Surgical Skin Closure Device

Non-woven adhesive wound dressing

3M™ Medipore™ +Pad Soft Cloth Adhesive Wound Dressing, 3564, Dressing - 2-3/8 in x 4 in, Pad - 1 in x 2-3/8 in

Hydrogel

Burr, Oval, 10 flute, 3.0mm

Precision Thin Offset (10.0 x 0.38 x 43.0mm)

Set Includes the following: 242-100-008 : 2.5 mm Grasper 242-100-004 : 2.1 mm Left Blunt Nose Grasper 242-100-005 : 2.1 mm Down Blunt Nose Grasper 242-100-006 : 2.1 mm Up Blunt Nose Grasper 242-100-002 :2.1 mm Straight Blunt Nose Grasper 242-100-012 : 2.7 mm Straight Blunt Nose 242-100-007 : 2.5 mm Championª Scissors 242-100-013 : 2.7 mm Up Blunt Nose

The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN steerable needle to fill the previously created void(s). An access channel is required for the Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device.If the balloon has an Articulating Stylet inserted it enables the steerable feature of the balloon. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existing channel. The Osseoflex® SB actuation knob can be turned clockwise to aid in directing the distal portion of the device. Turning the actuation knob counter-clockwise will relax the device and allow the device to be returned to it's start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.