Guardian-SG Inflatable Bone Expander System
Guardian-SG Inflatable Bone Expander System creates a space in cancellous bone during spinal fracture treatment and vertebral augmentation. It combines an inflatable bone tamp with a…
Guardian-SG Inflatable Bone Expander System creates a space in cancellous bone during spinal fracture treatment and vertebral augmentation. It combines an inflatable bone tamp with a compressor and procedure accessories.
The balloon catheter has a shaft, Y-hub and distal balloon. Radiopaque markers at the working segment allow fluoroscopic positioning, and silicone fluid on the balloon surface supports passage through a cannula.
Listed Item
The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of fracture and/or creation of a void in cancellous bone in the spine.
Expansion and Cement
Balloon expansion creates the void for the subsequent spinal augmentation step. The system is used with compatible PMMA bone cement intended for vertebral augmentation, including kyphoplasty. Balloon catheter, compressor and accessory-kit components are supplied sterile and disposable.
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 | BM Korea Co., Ltd., South Korea |
|---|---|
| FDA product code | NDN |
| Device type | Cement, Bone, Vertebroplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Manufacturer |
| 510(k) | K143006 |
| Record published | 2017-06-21 |
| Record revised | 2020-05-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: temperature limitation, from -10℃ to 25℃ |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BMK(T)15αS | 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 |
|---|---|
| K143006 | 2015-01-16 |
| K111593 | 2011-11-18 |
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.