Other products from "OSSEON LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 B330OT02220 OT-0222 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves 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. NDN,HRX Cement, Bone, Vertebroplasty,Arthroscope 2 Osseoflex SB Straight Balloon (10ga/2ml)
2 B330OF03480 OF-0348 Osseoflex® CD-H Hydraulic Cement Delivery system is a bone cement delivery devic Osseoflex® CD-H Hydraulic Cement Delivery system is a bone cement delivery device designed to allow the physician to keep a safer distance from the radiation source during the cement delivery phase in vertebroplasty, vertebral augmentation procedures and the skeletal system. KIH Dispenser, Cement 1 Osseoflex CD-H
3 B330PC02700 PC-0270 The Osseoflex PC Pre-Curved Bone Tamp is a mechanical device used to disrupt can The Osseoflex PC Pre-Curved Bone Tamp is a mechanical device used to disrupt cancellous bone by channeling through the bone creating a void within a vertebral body. The Osseoflex PC Pre-Curved Bone Tamp can be utilized for multiple level vertebral body access. The channel can be used to introduce an appropriately sized Osseon inflatable bone tamp. HXG Tamp 1 Osseoflex PC Pre-Curved Bone Tamp 10ga
4 B330OT02240 OT-0224 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves 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. NDN,HRX Cement, Bone, Vertebroplasty,Arthroscope 2 Osseoflex SB Straight Balloon (10ga/4ml)
5 B330OF82220 OF-8222 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves 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. NDN,HRX Cement, Bone, Vertebroplasty,Arthroscope 2 Osseoflex SB Steerable Balloon (8ga/2ml)
6 B330OF02240 OF-0224 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves 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. NDN,HRX Cement, Bone, Vertebroplasty,Arthroscope 2 Osseoflex SB Steerable Balloon ( 10 ga/ 4ml)
7 B330OF00050 OF-0005 The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves 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. NDN,HRX Cement, Bone, Vertebroplasty,Arthroscope 2 Osseoflex SB Steerable Balloon (8ga/ 4ml)
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
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24 03760177049420 SM-IN3001C SM-IN3001C INTROX® HighV TEKNIMED
25 03760177049413 SM-IN3001 SM-IN3001 INTROX® HighV spinal cement system TEKNIMED
26 03760177047419 NuVasive Maximum Viscosity Cement 10001158 NuVasive Maximum Viscosity Cement TEKNIMED
27 03760177047396 NuVasive Max. Visco. Cem. System 10001127 NuVasive Maximum Viscosity Spinal Cement System TEKNIMED
28 03760177047174 T040352 META + TEKNIMED
29 03760177046528 C10A C10A KYPHON ACTIVOS 10 TEKNIMED
30 03760177046399 MVX-P MVX-P MVX-PLUS TEKNIMED
31 03760177046368 INTV-CEMLV INTV-CEMLV OSTEOFLEX LV TEKNIMED
32 03760177046351 VCF-1009 VCF-1009 OSTEOFLEX TEKNIMED
33 03760177046344 11 CC 183901000 CONFIDENCE TEKNIMED
34 03760177046337 21390 21390 OSSEOFIX + TEKNIMED
35 03760177046313 HC-SX-SL HC-SX-SL Synth-X SL TEKNIMED
36 03760177046283 G90001/VBC-300 G90001/VBC-300 Thermalfix TEKNIMED
37 03760177046276 G90000/VBC-200 G90000/VBC-200 Osteofix TEKNIMED
38 03760177043954 66-VMD-100 66-VMD-100 VERTEMEND TEKNIMED
39 03760177043947 11 CC 183901000 CONFIDENCE TEKNIMED
40 03760177043930 VBC-100 VBC-100 VERTEFIX TEKNIMED
41 03760177043923 CM0300 CM0300 COHESION TEKNIMED
42 03760177043084 T040321K T040321K HIGH V+ SPINAL CEMENT SYSTEM TEKNIMED
43 03760177043060 VCF-1009 VCF-1009 ZVplasty TEKNIMED
44 03760177042933 INTV-CEM INTV-CEM OSTEOFLEX TEKNIMED
45 03760177042391 T040323 T040323 EXOFIX TEKNIMED
46 03760177042384 US040320S US040320S SPINE-FIX US TEKNIMED
47 03760177041721 T040321 T040321 HIGH V+ TEKNIMED
48 03760177041677 C10A C10A KYPHON ACTIVOS 10 TEKNIMED
49 03760177041110 T040520 T040520 F20 TEKNIMED
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