FDA device listing
Remex Spine Surgery Navigation System II,WatchTower spine navigation system
FDA device listing 2055035348 · INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT
Key facts
| Proprietary names | Remex Spine Surgery Navigation System II,WatchTower spine navigation system |
|---|---|
| Owner/operator | INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT |
| Owner/operator number | 10046565 |
| Product codes | OLO |
| Device names | OLO - Orthopedic Stereotaxic Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.4560 |
| Review panels | Neurology |
| Registered establishments | INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT |
| Establishment registrations | 3011187779 |
| FEI numbers | 3011187779 |
| Establishment operations | Contract Manufacturer |
| 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