SpineKure Kyphoplasty System
The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore sagittal alignment by creating a space in the vertebral body to facilitate the insertion of…
The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore sagittal alignment by creating a space in the vertebral body to facilitate the insertion of bone cement. The SpineKure Kyphoplasty System is comprised of a Balloon Catheter, Balloon Inflator and Cement Delivery System (Accessories kit). The Balloon Catheter’s main components are the shaft, hub and the inflatable balloon located at the distal tip. The surface of balloon is covered with a silicone lubricant to enhance the insertion and withdrawal of catheter. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Inflator (SBI) is a disposable device with an integral pressure gauge. The Cement Delivery System (SCDS) are consist of Bone Access Needle (SBN), Cement Filler & Pusher (SFP), Cannula & Expander (SCE), Drill Bit (SDB), Wire-pin (SWP-T, SWP-R).
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 | HAN Chang Co., Ltd. |
|---|---|
| FDA product code | NDN |
| Device type | Cement, Bone, Vertebroplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| 510(k) | K172871 |
| Record published | 2020-04-17 |
| Record revised | 2020-05-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Cement Delivery System (SCDS) | In distribution | |
| Balloon Catheter (SBC-10) | In distribution | |
| Balloon Catheter (SBC-15) | In distribution | |
| Balloon Inflator (SBI) | In distribution | |
| SpineKure Kyphoplasty System | In distribution | |
| Balloon Catheter (SBC-20) | 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
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.