FDA device listing
1.0mm Bushing for CMC Guide,1.0mm Bushing for Hallux Guide,1.4mm Bushing for CMC Guide,1.4mm Bushing for Hallux…
FDA device listing 1014143949 · Dunamis Medical LLC
Key facts
| Proprietary names | 1.0mm Bushing for CMC Guide,1.0mm Bushing for Hallux Guide,1.4mm Bushing for CMC Guide,1.4mm Bushing for Hallux Guide,CMC Guide,Dunamis Interference Screw Insertion Tool,Dunamis Pick,Dunamis Positioning Tool,Hallux Guide,Orca™ Flipper,Tensioners |
|---|---|
| Owner/operator | Dunamis Medical LLC |
| Owner/operator number | 10047203 |
| 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 | Dunamis Medical LLC |
| Establishment registrations | 3011061237 |
| FEI numbers | 3011061237 |
| Establishment operations | Manufacturer, 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