FDA device listing
3368 - Hana/ProFx 3IN SHORTENED PERINEAL POST,3369 - Hana/ProFx Large Diameter Perineal Post,3369R - PERINEAL POST…
FDA device listing 1983311079 · Mizuho Orthopedic Systems, Inc.
Key facts
| Proprietary names | 3368 - Hana/ProFx 3IN SHORTENED PERINEAL POST,3369 - Hana/ProFx Large Diameter Perineal Post,3369R - PERINEAL POST, LARGE DIAMETER, REFURB,3377L - PAD, LARGE MLPD BELLY, BLK,3377S - PAD, SMALL MLPD BELLY, BLK,5010 - PREP-ASSIST,5052-3 - ALP STRAPS W/FOAM BOOTS (PR),5275-5 - LEG ASSEMBLY, HAND SURGERY TABLE,5275-5R - LEG ASSEMBLY, HAND SURGERY TABLE, REFURB,5275 - RADIOLUCENT HAND SURGERY TABLE… |
|---|---|
| Owner/operator | Mizuho Orthopedic Systems, Inc. |
| Owner/operator number | 2921578 |
| Product codes | JEA |
| Device names | JEA - Table, Surgical With Orthopedic Accessories, Ac-Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4960 |
| Review panels | General & Plastic Surgery |
| Registered establishments | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Establishment registrations | 2921578 |
| FEI numbers | 2921578 |
| Establishment operations | 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