FDA device listing
IN-SITU ROD BENDER-LEFT,IN-SITU ROD BENDER-RIGHT
FDA device listing 1281628681 · CG MedTech Co., Ltd.
Key facts
| Proprietary names | IN-SITU ROD BENDER-LEFT,IN-SITU ROD BENDER-RIGHT |
|---|---|
| Owner/operator | CG MedTech Co., Ltd. |
| Owner/operator number | 9045343 |
| Product codes | HXP |
| Device names | HXP - Instrument, Bending Or Contouring |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | CG MedTech Co., Ltd., CG MedTech USA, Inc. |
| Establishment registrations | 9617297, 3009554293 |
| FEI numbers | 3003200961, 3009554293 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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