FDA device listing
02-120-00 GM-98 Spinal Frame,02-121-00 Four-point Spinal Frame,02-121-10 Radiolucent Carbon Fiber Four Point Spinal…
FDA device listing 1722953080 · MIZUHO Corporation
Key facts
| Proprietary names | 02-120-00 GM-98 Spinal Frame,02-121-00 Four-point Spinal Frame,02-121-10 Radiolucent Carbon Fiber Four Point Spinal Frame,03-001-73 Aluminium Armboard,03-001-74 Radiolucent Acrylic Armboard,08-007-20 Table Cart for 5700 Series,08-007-21 Back Section Board Short,08-007-21-R1 Back Section Board Short (R1),08-007-21-R2 Back Section Board Short (R2),08-007-22 Cervical Spine Frame,08-007-22-R1 Cervical… |
|---|---|
| Owner/operator | MIZUHO Corporation |
| Owner/operator number | 9007414 |
| Product codes | GDC |
| Device names | GDC - Table, Operating-Room, Electrical |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4960 |
| Review panels | General & Plastic Surgery |
| Registered establishments | MIZUHO CORPORATION, MIZUHO Corporation Chiba Factory, MIZUHO Corporation Gosen Factory, Mizuho (Thailand) Co., Ltd. |
| Establishment registrations | 9680242, 3008388379, 3010594257, 3011547624 |
| FEI numbers | 3008388379, 3009504761, 3010594257, 3011547624 |
| Establishment operations | Foreign Exporter, Manufacturer |
| 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