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Bone Screw 2x11 Headed Short Thread Cannulated Ti
GRAMERCY EXTREMITY ORTHOPEDICS LLC
10002011
In Commercial Distribution
- B471100020110 ()
- Outer Diameter: 2 Millimeter
- Length: 11 Millimeter
- Orthopaedic bone screw, non-bioabsorbable, sterile
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.
OSSEON LLC
OT-0224
In Commercial Distribution
- B330OT02240 ()
- Needle Gauge: 11 Gauge
- Total Volume: 4 Milliliter
- Inflatable bone tamp
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.
OSSEON LLC
OT-0222
In Commercial Distribution
- B330OT02220 ()
- Needle Gauge: 11 Gauge
- Total Volume: 2 Milliliter
- Inflatable bone tamp
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.
OSSEON LLC
OF-0224
In Commercial Distribution
- B330OF02240 ()
- Needle Gauge: 11 Gauge
- Total Volume: 4 Milliliter
- Inflatable bone tamp
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.
OSSEON LLC
OF-0222
In Commercial Distribution
- B330OF02220 ()
- Needle Gauge: 11 Gauge
- Total Volume: 2 Milliliter
- Inflatable bone tamp
ESOPHAGEAL APPLICATOR
Bionix Radiation Therapy, LLC
E-APP-1-VS
Not in Commercial Distribution
- 00817740020997 ()
- Length: 11 Centimeter
- BALLOON OUTER DIAMETER
- TREATMENT LENGTH OF BALLOONS
- Outer Diameter: 20 Millimeter
E-APP-1-VS
- Oesophagus brachytherapy system applicator, remote-afterloading
ESOPHAGEAL APPLICATOR
Bionix Radiation Therapy, LLC
E-APP-1
Not in Commercial Distribution
- 00817740020980 ()
- Length: 11 Centimeter
- Outer Diameter: 20 Millimeter
- BALLOON OUTER DIAMETER
- TREATMENT LENGTH OF BALLOONS
E-APP-1
- Oesophagus brachytherapy system applicator, remote-afterloading
THORA-VENT Procedure Tray - 11F 13cm
URESIL, LLC
TV11-13
In Commercial Distribution
- 10817640020766 ()
- 00817640020769 ()
- 20817640020763 ()
- H862TV11130 ()
- Catheter Gauge: 11 French
- Length: 13 Centimeter
TV11-13
- Pneumothorax catheter insertion set
THORA-VENT Procedure Tray - 11F 10cm
URESIL, LLC
TV11-10
In Commercial Distribution
- 10817640020759 ()
- 00817640020752 ()
- 20817640020756 ()
- H862TV11100 ()
- Catheter Gauge: 11 French
- Length: 10 Centimeter
TV11-10
- Pneumothorax catheter insertion set
Insertion Cannula for TV11-13
URESIL, LLC
OTW11-13
In Commercial Distribution
- 10817640020469 ()
- 00817640020462 ()
- 20817640020466 ()
- H862OTW11130 ()
- Catheter Gauge: 11 French
- Length: 13 Centimeter
OTW11-13
- Pneumothorax catheter insertion set