FDA device listing
CONCORDE,COUGAR,EXPEDIUM,Expedium Osteotomy,Expedium Powered Instruments,PULSE,Spotlight Access System,SYMPHONY…
FDA device listing 1136164791 · Medos International SARL
Key facts
| Proprietary names | CONCORDE,COUGAR,EXPEDIUM,Expedium Osteotomy,Expedium Powered Instruments,PULSE,Spotlight Access System,SYMPHONY OCT,VIPER,Viper Prime |
|---|---|
| Owner/operator | Medos International SARL |
| Owner/operator number | 10031083 |
| Product codes | FSM |
| Device names | FSM - Tray, Surgical, Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | MEDOS INTERNATIONAL SARL |
| Establishment registrations | 3008114965 |
| FEI numbers | 3008114965 |
| 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