AVAFLEX™ VERTEBRAL BALLOON SYSTEM 10GX15MM

AVAFLEX™ VERTEBRAL BALLOON SYSTEM 10GX20MM

AVAFLEX™ VERTEBRAL BALLOON SYSTEM 10GX20MM

AVAFLEX™ VERTEBRAL BALLOON SYSTEM 11GX15MM

AVAFLEX™ VERTEBRAL BALLOON SYSTEM 11GX20MM

AVAFLEX™ VERTEBRAL BALLOON SYSTEM 11GX30MM

AVAtex Radiopaque Bone Cement

AVAmax Bone Cement Delivery System

AVAmax Extra Level Tray, Bone Cement Delivery System

AVAMAX™ VERTEBRAL BALLOON TRAY 8GX10MM

AVAMAX™ VERTEBRAL BALLOON TRAY 8GX15MM

AVAMAX™ VERTEBRAL BALLOON TRAY 8GX20MM

AVAMAX™ VERTEBRAL BALLOON TRAY 10GX15MM

AVAMAX™ VERTEBRAL BALLOON TRAY 10GX20MM

AVAMAX™ VERTEBRAL BALLOON TRAY 11GX10MM

AVAMAX™ VERTEBRAL BALLOON TRAY 11GX15MM

AVAMAX™ VERTEBRAL BALLOON TRAY 11GX20MM

AVAMAX™ VERTEBRAL BALLOON TRAY 13GX10MM

AVAMAX™ VERTEBRAL BALLOON TRAY 13GX15MM

AVAMAX™ VERTEBRAL BALLOON TRAY 13GX20MM

AVAmax PLUS Bone Cement Delivery System

AVAmax PLUS Extra Level Tray Bone Cement Delivery System

Vertebroplasty Ancillary Kit

CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE KIT SPINAL CEMENT SYSTEM 5cc

CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11cc

CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE KIT SPINAL CEMENT SYSTEM

BONE CEMENT C01B HV-R WITH MIXER US

BONE CEMENT CX01B XPEDE W MIXER US

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 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 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. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existingchannel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

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.

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 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 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 its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

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 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 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. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existingchannel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

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 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 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 its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

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 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 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 its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

Mix Tips, Luer

INFLATION SYSTEM-STERILE

VERTEBRAL BODY BALLOON/SMALL- STERILE

VERTEBRAL BODY BALLOON/MEDIUM- STERILE

VERTEBRAL BODY BALLOON/LARGE- STERILE

SYNFLATE BALLOON/SMALL- STERILE

SYNFLATE BALLOON/MEDIUM- STERILE

SYNFLATE BALLOON/LARGE- STERILE

Mendec Spine is an acrylic resin for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure.Mendec Spine is a medium-high viscosity acrylic resin (PMMA-based), highly radiopaque for syringe application.The device is sold disposable and sterile

Mendec Spine Kit is a device for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedure.The device is composed by an acrylic resin and a delivery system.

Mendec Spine HV System is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure.Mendec Spine HV System is a closed sysyem which containes the powder and liquid components separately.The device is disposable and sterile.