FDA device listing
Screw Tab Breaker
FDA device listing 1967221744 · OSSEUS FUSION SYSTEMS LLC
Key facts
| Proprietary names | Screw Tab Breaker |
|---|---|
| Owner/operator | OSSEUS FUSION SYSTEMS LLC |
| Owner/operator number | 10045353 |
| Product codes | HXQ |
| Device names | HXQ - Crimper, Pin |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | OSSEUS FUSION SYSTEMS LLC |
| Establishment registrations | 3010531060 |
| FEI numbers | 3010531060 |
| Establishment operations | Repackager/Relabeler, 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