FDA device listing
B-Two Inflatable bone expander system balloon catheter,B-Two Inflatable bone expander system syringe,B-Two Vertebral…
FDA device listing 2027759723 · IMEDICOM Co., Ltd.
Key facts
| Proprietary names | B-Two Inflatable bone expander system balloon catheter,B-Two Inflatable bone expander system syringe,B-Two Vertebral access system,B-Two Vertebral Balloon Expand® Kyphoplasty System,MEDINAUT-I,MEDINAUT-Ix,MEDINAUT Kyphoplasty System,MEDINAUT-X |
|---|---|
| Owner/operator | IMEDICOM Co., Ltd. |
| Owner/operator number | 10041241 |
| Premarket submissions | K133669 |
| Product codes | HRX, NDN |
| Device names | HRX - Arthroscope, NDN - Cement, Bone, Vertebroplasty |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.1100, 888.3027 |
| Review panels | Orthopedic |
| Registered establishments | IMEDICOM CO., LTD. |
| Establishment registrations | 3009599228 |
| FEI numbers | 3009599228 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database