FDA device listing
ANAX™ OCT Spinal System
FDA device listing 1128571368 · CG MedTech Co., Ltd.
Key facts
| Proprietary names | ANAX™ OCT Spinal System |
|---|---|
| Owner/operator | CG MedTech Co., Ltd. |
| Owner/operator number | 9045343 |
| Premarket submissions | K251725 |
| Product codes | KWP, NKG |
| Device names | KWP - Appliance, Fixation, Spinal Interlaminal, NKG - Posterior Cervical Screw System |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3050, 888.3075 |
| Review panels | Orthopedic |
| Registered establishments | CG MedTech Co., Ltd., CG MedTech USA, Inc. |
| Establishment registrations | 9617297, 3009554293 |
| FEI numbers | 3003200961, 3009554293 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| 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