Tracker
The FDA filing identifies Tracker as the TRACKER Kyphoplasty System, an inflatable bone tamp. The system comprises TRACKER-X, P and TRACKER-I systems. It is intended to reduce fractures or…
The FDA filing identifies Tracker as the TRACKER Kyphoplasty System, an inflatable bone tamp. The system comprises TRACKER-X, P and TRACKER-I systems.
It is intended to reduce fractures or create a void in cancellous bone in the spine, tibia, radius and calcaneus. The filing includes use during percutaneous vertebral augmentation.
Listed Item
TRACKER-X Balloon Catheter
System Components
The GSK System consists of a TRACKER-P balloon expander and TRACKER-X balloon catheter. TRACKER-I is a cement dispenser kit for percutaneous bone access and bone cement delivery. The TRACKER-I System is sold only as a system.
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) | K192335 |
| Record published | 2019-12-30 |
| Record revised | 2021-02-03 (version 2) |
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 |
|---|---|---|
| GSK-15-E | In distribution | |
| GCD2-CP1-E | In distribution | |
| GSK-BOO-E | In distribution | |
| GCD-WP1-E | In distribution | |
| GCD-ND1-E | In distribution | |
| GCD-EX1-E | 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 |
| 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.