FDA UDI
In Commercial Distribution
🇺🇸 United States
BALEX Bone Expander System
DI: 08809281659370
·
Model: BALEX TYP 0515
·
Taeyeon Medical co.,Ltd.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BALEX Bone Expander System
- Primary DI
- 08809281659370
- Version / Model
- BALEX TYP 0515
- Catalog Number
- TYP 0515
- Company Name
- Taeyeon Medical co.,Ltd.
- Labeler DUNS
- 687607387
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-22
- Public Version
- 1
- Public Version Date
- 2025-09-01
- Public Version Status
- New
- Public Device Record Key
- f09a1ed1-a445-4784-ac21-ba26825328b5
Device Description
BALEX Bone Expander Systems are the device intended to insert the bone cement into the cavity made by the balloon tip in the fractures of the spinal bone. The kit box includes 1 kit which contains the Balloon Expander and Catheter.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HXG | Tamp | Orthopedic | 888.4540 | 1 |
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | 888.3027 | 2 |
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58020 | Kyphoplasty balloon catheter | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809281659370 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202027 | 000 |