| 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 | B330OF02220 | OF-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 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. | NDN,HRX | Cement, Bone, Vertebroplasty,Arthroscope | 2 | Osseoflex SB Steerable Balloon (10ga/2ml) | |
| 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) |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B07330K0160400 | 30-K01-6040 | 30-K01-6040 | Tamp, Angled | Navagio | KALITEC DIRECT LLC |
| 2 | B07330K0160300 | 30-K01-6030 | 30-K01-6030 | Tamp, Footed | Navagio | KALITEC DIRECT LLC |
| 3 | B07330K0160200 | 30-K01-6020 | 30-K01-6020 | Tamp, Straight | Navagio | KALITEC DIRECT LLC |
| 4 | B07330K0160100 | 30-K01-6010 | 30-K01-6010 | Tamp, Starter | Navagio | KALITEC DIRECT LLC |
| 5 | B07323K0107100 | 23-K01-0710 | Tamp, Rotating | TiWAVE L Lumbar Cage System | KALITEC DIRECT LLC | |
| 6 | B07323K0107000 | 23-K01-0700 | Tamp, Advancing | TiWAVE L Lumbar Cage System | KALITEC DIRECT LLC | |
| 7 | B07319K0162400 | 19-K01-6240 | 19-K01-6240 | Tamp, Bone Funnel | Kalitec Disc Prep | KALITEC DIRECT LLC |
| 8 | B07311K0150040 | 11-K01-5004 | Tamp, Cross Link | CosmoLock Pedicle Screw System | KALITEC DIRECT LLC | |
| 9 | B07309K0100090 | 09-K01-0009 | Tamp, Oblique Kicker | InTess C Cervical Cage System | KALITEC DIRECT LLC | |
| 10 | B07309K0100010 | 09-K01-0001 | Tamp, Modular Tip, InTess C | InTess C Cervical Cage System | KALITEC DIRECT LLC | |
| 11 | B06217500100 | 1750-0002 | 1750-0002 | Tamp | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 12 | B06217500004 | 1750-0004 | 1750-0004 | Tamp, Angled, Oblique | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 13 | B06217500003 | 1750-0003 | 1750-0003 | Tamp, Angled, Medial | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 14 | M930863111100 | 863-1111-0 | Bone Tamp 11" 11mm x 3mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 15 | M930763951500 | 763-9515-0 | Round Bone Tamp 5mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 16 | M930763951300 | 763-9513-0 | Bone Tamp (Round) 13mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 17 | M930763951210 | 763-9512-1 | Smith Peterson Bone Impactor 9.5" | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 18 | M930763951200 | 763-9512-0 | Custom Bone Tamp 9.5" length | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 19 | M9307639510300 | 763-9510-30 | Bone Impactor 30 Deg. Offset | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 20 | M930763951030 | 763-9510-3 | Offset Bone Tamp Special Curve | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 21 | M93076395100C0 | 763-9510-0C | Custom Offset Bone Tamp 6" working length; 9" Handle | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 22 | M9307639510010 | 763-9510-0-1 | Custom Offset Bone Tamp 90° 3x6mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 23 | M930763951000 | 763-9510-0 | Bone Tamp (Offset) 10mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 24 | M930763950800 | 763-9508-0 | Round Bone Tamp 8mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 25 | M930763950600 | 763-9506-0 | Round Bone Tamp 6mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 26 | M930763950500 | 763-9505-0 | Bone Tamp (Rectangular) 5mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 27 | M930763950400 | 763-9504-0 | Round Bone Tamp 4mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 28 | M930763950300 | 763-9503-0 | Round Bone Tamp 3mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 29 | M930763950200 | 763-9502-0 | Round Bone Tamp 2mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 30 | M930763950000 | 763-9500-0 | Bone Tamp Set | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 31 | M93076370130C0 | 763-7013-0C | Custom Tamp 180mm "Goalpost" 10mm opening | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 32 | M93076370120C0 | 763-7012-0C | Custom Tamp 180mm "Goalpost" 9mm opening | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 33 | M93076370100C0 | 763-7010-0C | Custom Tamp 180mm "Goalpost" 7mm opening | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 34 | M93076360100C0 | 763-6010-0C | Custom Tamp 150mm "Goalpost" 7mm opening | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 35 | M930763181000 | 763-1810-0 | Anterior Bone Tamp 10mm diameter | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 36 | M93076318080C0 | 763-1808-0C | Custom 18" Tamp 8mm Tip | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 37 | M9307631558110 | 763-1558-1-1 | Long Impactor 15mmx6mm, 15" | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 38 | M9307631410OC0 | 763-1410-OC | offset bone impactor | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 39 | M93076314101C0 | 763-1410-1C | offset bone impactor custom angle 30 deg at 25mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 40 | M93076314080C0 | 763-1408-0C | Custom Bone Tamp 14" 5" handle | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 41 | M9307631405010 | 763-1405-0-1 | Tamp 14" 90 deg 5mmx6mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 42 | M930763140500 | 763-1405-0 | Downpusher Tamp 5x13mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 43 | M930763131610 | 763-1316-1 | Bone Tamp (Offset) 16mm Angled | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 44 | M930763131500 | 763-1315-0 | 15mm Bone Tamp | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 45 | M930763131200 | 763-1312-0 | Bone Tamp 13.5" 12 x 19mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 46 | M930763130800 | 763-1308-0 | Custom Rnd Bone Tamp 13" 8mm 5"X1" Handle | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 47 | M930763130600 | 763-1306-0 | Custom Rnd BoneTamp 13" 6mm 5"x1" Handle | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 48 | M930763130400 | 763-1304-0 | Offset Bone Tamp 13" 4x16mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 49 | M930763130300 | 763-1303-0 | Offset Bone Tamp 13" 3x16mm | Life Instruments | LIFE INSTRUMENT CORPORATION | |
| 50 | M930763130000 | 763-1300-0 | Bone Impactor | Life Instruments | LIFE INSTRUMENT CORPORATION |