Tracker Plus Kyphoplasty System
TRACKER Plus is an inflatable bone-tamp system for reducing fractures or creating a cavity in cancellous bone. Applications include percutaneous vertebral augmentation, with additional…
TRACKER Plus is an inflatable bone-tamp system for reducing fractures or creating a cavity in cancellous bone. Applications include percutaneous vertebral augmentation, with additional indicated sites in the tibia, radius and calcaneus.
Its balloon catheter is used with a cement dispenser kit and cement mixing system. The associated bone-cement application uses cleared spinal PMMA cements indicated for percutaneous vertebral augmentation.
Kit Components
The system includes an expander syringe and access components such as a cannula, guidewire, cement pusher and filler. The cement dispenser and mixing system are sold separately from the balloon catheter. These parts provide balloon expansion, access and cement-handling functions within the procedural family.
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 | GS Medical 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) | K211797 |
| Record published | 2022-10-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GCD-N1400 | In distribution | |
| GCD-F1000 | In distribution | |
| GCD-N1600 | In distribution | |
| GSB-1120 | In distribution | |
| GCD-FD1000 | In distribution | |
| GSMD-00 | In distribution | |
| GSMD-11 | In distribution | |
| GSFB-1110 | In distribution | |
| GCD-FD1100 | In distribution | |
| GCD-N1300 | In distribution | |
| GSBB-00 | In distribution | |
| GCD-S1000 | In distribution | |
| GSD-1000 | In distribution | |
| GSB-1110 | In distribution | |
| GSIG-00 | In distribution | |
| GSDK-01 | In distribution | |
| GSFB-1115 | In distribution | |
| GCD-FF1000 | In distribution | |
| GVCD-1000 | In distribution | |
| GCD-1000 | In distribution | |
| GCD-N1500 | In distribution | |
| GCD-N1000 | In distribution | |
| GSCK-01 | In distribution | |
| GSFB-1120 | In distribution | |
| GSB-1115 | 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 |
| 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 |
| Spider Kolibri | Sintea Plustek | 6 |
Showing 12 of 210. All products under Cement, Bone, Vertebroplasty
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211797 | 2021-10-28 |
| K192335 | 2019-12-04 |
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.