Balex Bone Expander System
Kyphoplasty balloon catheter Definition: A sterile, flexible tube designed to be used for the creation of a void within a vertebral body during a minimally invasive procedure commonly known…
Kyphoplasty balloon catheter Definition: A sterile, flexible tube designed to be used for the creation of a void within a vertebral body during a minimally invasive procedure commonly known as balloon kyphoplasty. It is manually inserted percutaneously through an access channel under fluoroscopic guidance to a vertebral compression fracture (VCF) site (e.g., in the lumbar or thoracic region of the spine) where its balloon is inflated with a medium (e.g., a liquid contrast medium) to force the vertebrae apart for insertion of bone cement; thereafter it is deflated and removed via the access channel. This is a single-use device.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Lange Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 16 |
| Jiangsu Changmei Medtech Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Taeyeon Medical Co., Ltd., South Korea |
|---|---|
| FDA product code | HXG |
| Device type | Tamp |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer |
| 510(k) | K202027 |
| Record published | 2025-08-22 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BALEX TYP 0515 | In distribution | |
| BALEX TYP 0510 | In distribution | |
| BALEX TYP 0520 | In distribution | |
| BALEX TYP 0520 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 78 |
| Life Instruments | Life Instrument Corp. | 56 |
| 4WEB Medical | 4WEB Inc. | 35 |
| General Instruments | Alphatec Spine, Inc. | 31 |
| CPT® | Zimmer, Inc. | 30 |
| Novel | Alphatec Spine, Inc. | 29 |
| IdentiTi | Alphatec Spine, Inc. | 29 |
| Tamp | Depuy Spine, Inc. | 27 |
| Tamp | Synthes Gmbh | 21 |
| Boss Instruments | Boss Instruments, Ltd. | 19 |
| Millennium | Avalign Technologies, Inc. | 18 |
| Aesculap | Aesculap AG | 17 |
Showing 12 of 267. All products under Tamp
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.