FDA device listing
STAPLE INSERTER
FDA device listing 1830539983 · SYNTHES GMBH / Synthes Produktions GmbH
Key facts
| Proprietary names | STAPLE INSERTER |
|---|---|
| Owner/operator | SYNTHES GMBH / Synthes Produktions GmbH |
| Owner/operator number | 9071542 |
| Product codes | HXJ |
| Device names | HXJ - Staple Driver |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | SYNTHES GMBH |
| Establishment registrations | 3009417901 |
| FEI numbers | 3009417901 |
| Establishment operations | Specification Developer |
| 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