FDA device listing
FIXATION PIN INSERTER, PREF ACP,FIXATION PIN, PREF ACP,FIXATION SCREW, PREF ACP,Gemini-C Inserter,Gemini-C Trial,GUIDE…
FDA device listing 1864586274 · OSSEUS FUSION SYSTEMS LLC
Key facts
| Proprietary names | FIXATION PIN INSERTER, PREF ACP,FIXATION PIN, PREF ACP,FIXATION SCREW, PREF ACP,Gemini-C Inserter,Gemini-C Trial,GUIDE WIRE, PREF ACP,LOCKING DRIVER, PREF ACP,Rod Holder,Rod Passer Driver,Rod Pusher,Rod Rocker |
|---|---|
| Owner/operator | OSSEUS FUSION SYSTEMS LLC |
| Owner/operator number | 10045353 |
| Product codes | LXH |
| Device names | LXH - Orthopedic Manual Surgical Instrument |
| 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