Kyphoplasty systems
Tracker Plus Kyphoplasty System
A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.
Where to buy Tracker Plus Kyphoplasty System
We do not have contact details for GS Medical Co., Ltd. yet. Send a request and we will route it to the right person for your country.
Tracker Plus Kyphoplasty System models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| GCD-1000 | — | Not stated | Available |
| GCD-F1000 | — | Not stated | Available |
| GCD-FD1000 | — | Not stated | Available |
| GCD-FD1100 | — | Not stated | Available |
| GCD-FF1000 | — | Not stated | Available |
| GCD-N1000 | — | Not stated | Available |
| GCD-N1300 | — | Not stated | Available |
| GCD-N1400 | — | Not stated | Available |
| GCD-N1500 | — | Not stated | Available |
| GCD-N1600 | — | Not stated | Available |
| GCD-S1000 | — | Not stated | Available |
| GSB-1110 | — | Not stated | Available |
| GSB-1115 | — | Not stated | Available |
| GSB-1120 | — | Not stated | Available |
| GSBB-00 | — | Not stated | Available |
| GSCK-01 | — | Not stated | Available |
| GSD-1000 | — | Not stated | Available |
| GSDK-01 | — | Not stated | Available |
| GSFB-1110 | — | Not stated | Available |
| GSFB-1115 | — | Not stated | Available |
| GSFB-1120 | — | Not stated | Available |
| GSIG-00 | — | Not stated | Available |
| GSMD-00 | — | Not stated | Available |
| GSMD-11 | — | Not stated | Available |
| GVCD-1000 | — | Not stated | Available |
FDA clearances
- 510(k) K211797 October 2021
Procedures that use kyphoplasty systems
Frequently asked questions
What is Tracker Plus Kyphoplasty System used for?
A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.
Who makes Tracker Plus Kyphoplasty System?
Tracker Plus Kyphoplasty System is made by GS Medical Co., Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Tracker Plus Kyphoplasty System come in?
The FDA device database does not list sizes for Tracker Plus Kyphoplasty System. Check the instructions for use or ask a GS Medical Co., Ltd. representative.
Is Tracker Plus Kyphoplasty System MRI safe?
The FDA device database entry for Tracker Plus Kyphoplasty System does not state its MRI safety status. Check the labeling before MRI.
Is Tracker Plus Kyphoplasty System FDA cleared?
Tracker Plus Kyphoplasty System is covered by FDA submission K211797.
How do I contact a GS Medical Co., Ltd. sales representative?
GS Medical Co., Ltd. has not listed representatives on LA Vascular yet. Visit the GS Medical Co., Ltd. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.