Medinaut-X(IBE System)
Medinaut-X is the inflatable bone-expander portion of the Medinaut kyphoplasty system. It is used to reduce fractures or create a void in cancellous bone in the spine, tibia, radius or…
Medinaut-X is the inflatable bone-expander portion of the Medinaut kyphoplasty system. It is used to reduce fractures or create a void in cancellous bone in the spine, tibia, radius or calcaneus, including during percutaneous vertebral augmentation.
The assembly contains a balloon catheter and bone-expander syringe. The catheter has a shaft, Y-shaped hub and distal inflatable balloon. Markers at the ends of the balloon’s working surface allow its position to be seen with fluoroscopy before inflation.
Single-Use Components
The catheter and syringe are supplied sterile for disposal after use. The balloon is thermoplastic polyurethane, with a silicone-fluid surface coating that helps it pass through the cannula.
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Ningbo Hicren Biotechnology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 5 |
| Jieno Youcheng Medical Technology (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 3 |
| Dragon Crown Medical Co., Ltd. | Jinan | Shandong | Manufacturer | 2 |
Record
| Listed by | Imedicom Co., Ltd., South Korea |
|---|---|
| FDA product code | NDN |
| Device type | Cement, Bone, Vertebroplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K153296 |
| Record published | 2016-09-27 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IBE-15 | In distribution | |
| IBE-10 | In distribution | |
| IBEX20 | In distribution | |
| IBE-20 | In distribution | |
| IBEX15 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zavation | Zavation | 284 |
| CD Horizon® Fenestrated Screw Set | Medtronic Sofamor Danek, Inc. | 88 |
| StabiliT® | Merit Medical Systems, Inc. | 42 |
| Medinaut Plus Kyphoplasty System | Imedicom Co., Ltd. | 41 |
| iVAS | Stryker GmbH | 35 |
| V-Strut Vertebral Implant | Hyprevention | 28 |
| Tracker Plus Kyphoplasty System | GS Medical Co., Ltd. | 25 |
| StabiliT MX Fracture Kit | Dfine, Inc. | 12 |
| Osseoflex® | Merit Medical Systems, Inc. | 8 |
| Synth™ BES | Imedicom Co., Ltd. | 8 |
| Tracker | GS Medical Co., Ltd. | 6 |
| AVAflex | Stryker GmbH | 6 |
Showing 12 of 210. All products under Cement, Bone, Vertebroplasty
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153296 | 2016-07-29 |
| K133669 | 2014-04-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.