| 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 | 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) | |
| 5 | 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) | |
| 6 | 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) | |
| 7 | 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) |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 04260200314109 | 1002-TS 010 | TOM Endo Stick | MaxMoreSpine | HOOGLAND SPINE PRODUCTS GMBH | |
| 2 | 04260200314093 | 1002-TS 009 | TOM Endo Stick | MaxMoreSpine | HOOGLAND SPINE PRODUCTS GMBH | |
| 3 | 04260200314086 | 1002-TS 008 | TOM Endo Stick | MaxMoreSpine | HOOGLAND SPINE PRODUCTS GMBH | |
| 4 | 04260200314079 | 1002-TS 007 | TOM Endo Stick | MaxMoreSpine | HOOGLAND SPINE PRODUCTS GMBH | |
| 5 | 04260200311832 | 1002-TS 005 | TOM Endo Stick 2,1 mm short | MaxMoreSpine | HOOGLAND SPINE PRODUCTS GMBH | |
| 6 | 04260200311795 | 1002-TS 002 | TOM Endo Stick 2,1 mm | MaxMoreSpine | HOOGLAND SPINE PRODUCTS GMBH | |
| 7 | 04260200311153 | 1002-TS 003 | TOM Endo Stick 4,1 mm | MaxMoreSpine | HOOGLAND SPINE PRODUCTS GMBH | |
| 8 | 04260200311146 | 1002-TS 001 | TOM Endo Stick 3,7 mm | MaxMoreSpine | HOOGLAND SPINE PRODUCTS GMBH | |
| 9 | 04260200311139 | 1002-TS 004 | TOM Endo Stick | MaxMoreSpine | HOOGLAND SPINE PRODUCTS GMBH | |
| 10 | 04260102132597 | plus | 66045747 | OSTEOPAL® plus is a radiopaque, low-viscosity bonecement, based on polymethyl me OSTEOPAL® plus is a radiopaque, low-viscosity bonecement, based on polymethyl methacrylate with anextended application phase, used to fill and stabilize vertebral bodies. OSTEOPAL® plus contains zirconium dioxide as an X-ray contrast agent. OSTEOPAL® plus contains the coloring agent chlorophyll VIII (E141) to improve visibility in the surgical field. The bone cement is prepared immediately prior to use by mixing the polymer powder component and the liquid monomer component. A low viscosity paste is applied with the use of application system, placed in the vertebral body, where it cures. OSTEOPAL® plus conforms to ISO 5833 except Annex C | OSTEOPAL® | HERAEUS MEDICAL GMBH |
| 11 | 04260102130494 | V | 66031896 | Osteopal® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It i Osteopal® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It is formed from powder and liquid by exothermic polymerization | OSTEOPAL® | HERAEUS MEDICAL GMBH |
| 12 | 04260056883231 | 01-0309 | BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery l BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. Mixing the two separate sterile components initially produces a ductile, injectable bone cement which, after hardening in situ, is able to stabilize neoplastic vertebral lesions and vertebral compression fractures. BonOs® Inject cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. | BonOs Inject | OSARTIS GMBH | |
| 13 | 04260056880759 | 08.702.017S | 08.702.017S | Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treat Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a Vertebroplasty or Kyphoplasty procedure. | Vertecem II Cement Kit | OSARTIS GMBH |
| 14 | 04250480108369 | 21.0061a | Arthroscope 4 x 157 mm, 30° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 15 | 04250480106303 | 48760512 | Arthroscope + Spine endoscope, 4 x 167 mm, 30° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 16 | 04250480106297 | 48760511 | Spine endoscope, 4 x 75 mm, 90° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 17 | 04250480101964 | 21.0623a | Arthroscope 2.0 x 110 mm, 30° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 18 | 04250480101957 | 21.0622a | Arthroscope 2.0 x 110 mm, 0° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 19 | 04250480101926 | 21.0621a | Arthroscope 2.7 x 187 mm, 70° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 20 | 04250480101896 | 21.0619a | Arthroscope 2.7 x 187 mm, 30° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 21 | 04250480101872 | 21.0617a | Arthroscope 2.7 x 187 mm, 0° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 22 | 04250480101636 | 21.0101a | Arthroscope 4 x 175 mm, 45° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 23 | 04250480101612 | 21.0081a | Arthroscope 4 x 142 mm, 30° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 24 | 04250480101605 | 21.0066a | Arthroscope 4 x 160 mm, 30° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 25 | 04250480101582 | 21.0053a | Arthroscope 4 x 170 mm, 70° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 26 | 04250480101568 | 21.0051a | Arthroscope 4 x 170 mm, 30° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 27 | 04250480101544 | 21.0013a | Arthroscope 4 x 175 mm, 30° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 28 | 04250480101520 | 21.0011a | Arthroscope 4 x 175 mm, 70° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 29 | 04250480101490 | 21.0008a | Arthroscope 4 x 175 mm, 30° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 30 | 04250480101476 | 21.0003a | Arthroscope 4 x 175 mm, 0° | NA | SCHÖLLY FIBEROPTIC GMBH | |
| 31 | 04250337118480 | FS6342181O-4K | FS6342181O-4K | 4K UHD Foraminoscope | joimax® | JOIMAX GMBH |
| 32 | 04250337118473 | FS6342181C-4K | FS6342181C-4K | 4K UHD Foraminoscope | joimax® | JOIMAX GMBH |
| 33 | 04250337118411 | FS7347171-15O | FS7347171-15O | TESSYS® FHD Foraminoscope (4.7 WCh), ocular | TESSYS® | JOIMAX GMBH |
| 34 | 04250337118404 | FS7347171-15C | FS7347171-15C | TESSYS® FHD Foraminoscope (4.7 WCh), combo | TESSYS® | JOIMAX GMBH |
| 35 | 04250337117650 | FS5831120O | FS5831120O | TESSYS® FHD Foraminoscope thoracic (3.1 WCh), ocular | TESSYS® | JOIMAX GMBH |
| 36 | 04250337117643 | FS5831120C | FS5831120C | TESSYS® FHD Foraminoscope thoracic (3.1 WCh), Combo | TESSYS® | JOIMAX GMBH |
| 37 | 04250337116325 | FS6342181-15O | FS6342181-15O | TESSYS® FHD Foraminoscope (3.7 WCh), ocular | TESSYS® | JOIMAX GMBH |
| 38 | 04250337116318 | LS7347150O | LS7347150O | iLESSYS® Pro FHD Laminoscope (4.7 WCh), Ocular | iLESSYS® | JOIMAX GMBH |
| 39 | 04250337116028 | FS6342181-15C | FS6342181-15C | TESSYS® FHD Foraminoscope (3.7 WCh), combo | TESSYS® | JOIMAX GMBH |
| 40 | 04250337116011 | LS7347150C | LS7347150C | iLESSYS® Pro FHD Laminoscope (4.7 WCh), Combo | iLESSYS® | JOIMAX GMBH |
| 41 | 04250337114697 | LS7347068C | CESSYS® Dorsal FHD Laminoscope (4.7 WCh), combo | CESSYS® | JOIMAX GMBH | |
| 42 | 04250337114680 | LS7347068O | CESSYS® Dorsal FHD Laminoscope (4.7 WCh), ocular | CESSYS® | JOIMAX GMBH | |
| 43 | 04250337114321 | CH402150C | FHD Hybrid Scope, combo | joimax® | JOIMAX GMBH | |
| 44 | 04250337111252 | FS6342125O | HD Laminoscope [3.7 mm WCh] with ocular | joimax® | JOIMAX GMBH | |
| 45 | 04250337111245 | FS6342125C | HD Laminoscope [3.7 mm WCh] | joimax® | JOIMAX GMBH | |
| 46 | 04250337111238 | FHD6336171O | Full HD Foramino- / Laminoscope with ocular | joimax® | JOIMAX GMBH | |
| 47 | 04250337111221 | FHD6336171C | Full HD Foramino- / Laminoscope | joimax® | JOIMAX GMBH | |
| 48 | 04250337110583 | FS7347171C | TESSYS® FHD Foraminoscope (4.7 WCh), combo | TESSYS® | JOIMAX GMBH | |
| 49 | 04250337110576 | FS7347171O | TESSYS® FHD Foraminoscope (4.7 WCh), ocular | TESSYS® | JOIMAX GMBH | |
| 50 | 04250337109679 | PS1909132O | HD Nucleoscope [1.9 mm OD] Ocular | joimax® | JOIMAX GMBH |